Page last updated: 2024-12-05

phentermine

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Description

Phentermine is a sympathomimetic amine, meaning it stimulates the sympathetic nervous system. It is a Schedule IV controlled substance in the United States, indicating it has a lower potential for abuse than Schedule I-III drugs. It is prescribed for short-term use in weight management, typically alongside diet and exercise, and is thought to work by suppressing appetite. Phentermine's synthesis involves the reaction of 2-phenylpropionaldehyde with methylamine, resulting in the formation of N-methyl-2-phenylpropan-1-amine. Studies on phentermine are focused on understanding its long-term safety and efficacy, its role in obesity management, and potential interactions with other medications. Research is also investigating its potential for treating conditions like attention-deficit/hyperactivity disorder (ADHD) and narcolepsy.'

Phentermine: A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID4771
CHEMBL ID1574
CHEBI ID8080
SCHEMBL ID26615
MeSH IDM0016536

Synonyms (94)

Synonym
mg 18570
2-methyl-1-phenylpropan-2-amine
dea no. 1640
2-amino-2-methyl-1-phenylpropane
hsdb 3158
mirapront
alpha,alpha-dimethyl-beta-phenylethylamine
phentermine [usan:inn:ban]
phentrol 4
omnibex
einecs 204-522-1
lonamin
phentrol 2
benzeneethanamine, alpha,alpha-dimethyl-
linyl
phenethylamine, alpha,alpha-dimethyl-
normephentermine
phenterminum [inn-latin]
alpha,alpha-dimethylbenzeneethanamine
rcra waste number p046
lipopill
phenyl-tert-butylamine
rcra waste no. p046
alpha-benzylisopropylamine
ethanamine, 1,1-dimethyl-2-phenyl-
2-phenyl-tert-butylamine
phenyl-tertiary-butylamine
obermine
phentrol
fentermina [inn-spanish]
1,1-dimethyl-2-phenylethylamine
brn 0970319
phentrol 3
phenethylamine, .alpha.,.alpha.-dimethyl-
benzeneethanamine, .alpha.,.alpha.-dimethyl-
phenterminum
CHEBI:8080 ,
fentermina
D05458
phentermine (usan/inn)
alpha,alpha-dimethylphenethylamine
C07438
phentermine
122-09-8
DB00191
phentermine resin
D1291
inchi=1/c10h15n/c1-10(2,11)8-9-6-4-3-5-7-9/h3-7h,8,11h2,1-2h
HMS2093B16
bdbm50246598
nsc-759163
CHEMBL1574 ,
AKOS004123261
unii-c045tql4wp
c045tql4wp ,
nsc 759163
ec 204-522-1
nsc759163
pharmakon1600-01505660
(alpha,alpha)-dimethylphenethylamine
AB02355
phentermine [mi]
phentermine [hsdb]
phentermine [mart.]
qsymia component phentermine
phentermine [usan]
phentermine [who-dd]
phentermine component of qsymia
phentermine [inn]
phentermine [vandf]
1,1-dimethyl-2-phenyl-ethylamine
gtpl7269
SCHEMBL26615
.alpha.,.alpha.-dimethylphenethylamine
.alpha..alpha.dimethylphenethylamine
1-benzyl-iso-propyl amine
DTXSID9023461 ,
sr-05000001805
SR-05000001805-2
SR-05000001805-1
phentermine 0.1 mg/ml in methanol
phentermine 1.0 mg/ml in methanol
SBI-0206817.P001
FT-0716831
Q418157
BRD-K96319534-001-01-7
122-09-8 (free base)
NCGC00263911-02
phentermine resiner
dtxcid303461
phenterminum (inn-latin)
phentermine (mart.)
a08aa01
fentermina (inn-spanish)

Research Excerpts

Overview

Phentermine is an old and low-cost agent given as an adjuvant therapy for obesity for a 12-week period. Phentermine/topiramate ER is an effective and safe weight-loss medication that can produce and sustain approximately 10% loss of body weight.

ExcerptReferenceRelevance
"Phentermine is an internationally recognised amphetamine derivative with significant appetite-suppressing properties. "( Potential drug-drug interactions with phentermine among long-term phentermine consumers: A retrospective analysis.
Du Plessis, JM; Fourie, A; Julyan, M; Mostert, L, 2023
)
2.62
"Phentermine is an old and low-cost agent given as an adjuvant therapy for obesity for a 12-week period, at an initial dose of 15 mg or 30 mg."( Three- and six-month efficacy and safety of phentermine in a Mexican obese population.
Barranco-Garduño, LM; Carrasco-Portugal, MDC; Huerta-Cruz, JC; Kammar-García, A; Márquez-Cruz, M; Reyes-García, JG; Rocha González, HI; Rodríguez-Silverio, J, 2021
)
1.6
"Phentermine is an isomer of methamphetamine though is not optically active such as e."( [Phentermine--a "weighty" or a dangerous substance?].
Jantos, R; Skopp, G,
)
1.76
"Phentermine/topiramate ER is an effective and safe weight-loss medication that can produce and sustain approximately 10% loss of body weight. "( Phentermine and topiramate extended-release: a new treatment for obesity and its role in a complications-centric approach to obesity medical management.
Garvey, WT, 2013
)
3.28
"Phentermine is a sympathomimetic agent found commonly in weight-loss products. "( Subarachnoid hemorrhage in a patient taking phentermine for weight loss.
Bain, JA; Cook, AM; Dority, JS,
)
1.84
"Phentermine is a noradrenergic sympathomimetic amine approved for short-term treatment of obesity."( Phentermine, topiramate and their combination for the treatment of adiposopathy ('sick fat') and metabolic disease.
Bays, H, 2010
)
2.52
"Phentermine is a viable and important adjunct in the medical approach to weight management in obese subjects. "( A case of profound weight loss secondary to use of phentermine.
Koch, CA; McDonald, A; Melcescu, E; Uwaifo, GI, 2009
)
2.05
"Phentermine hydrochloride is a noradrenergic sympathetic amine approved for decades by the U.S. "( Phentermine/topiramate for weight reduction and treatment of adverse metabolic consequences in obesity.
Bays, HE; Gadde, KM, 2011
)
3.25
"Phentermine is an appetite suppressant, while topiramate is an anti-epileptic medication."( Phentermine and topiramate extended release (Qsymia™): first global approval.
Cameron, F; McKeage, K; Whiteside, G, 2012
)
2.54
"Phentermine is a central nervous system stimulant that can increase brain dopamine levels and has a structure similar to amphetamine. "( Schizophreniform-like psychotic disorder induced by phentermine: a case report.
Lee, SH; Liu, CY; Yang, YY, 1998
)
1.99
"Chlorphentermine is a cationic amphiphilic drug which produces a phospholipid storage disorder in rat lungs. "( Alterations in rat alveolar surfactant phospholipids and proteins induced by administration of chlorphentermine.
Bowman, L; Miles, PR; Reasor, MJ; Tucker, J; Wright, JR, 1986
)
1

Effects

Phentermine has been considered a relatively safe drug to treat obesity. Chlorphentermine (CP) has been noted to cause primary pulmonary hypertension both clinically and experimentally.

ExcerptReferenceRelevance
"Phentermine/topiramate has considerable benefit in reducing body weight, and the efficacy was closely related to the dosage. "( Efficacy and Safety of Phentermine/Topiramate in Adults with Overweight or Obesity: A Systematic Review and Meta-Analysis.
Lai, C; Lei, XG; Ruan, JQ; Sun, Z; Yang, X, 2021
)
2.37
"Phentermine has been considered a relatively safe drug to treat obesity, and further investigation is needed to decide the safety and dosage of phentermine."( Pulmonary hypertension associated with use of phentermine.
Bang, WD; Chang, HJ; Cho, SS; Jang, JY; Joung, B; Kim, JY; Oh, CM; Yu, HT, 2010
)
1.34
"Phentermine (PT) has been widely used as an anti-obesity drug. "( Detection of phentermine in hair samples from drug suspects.
Choi, H; Chung, H; Chung, KH; In, S; Kim, J; Lee, S, 2011
)
2.18
"Chlorphentermine (CP) has been noted to cause primary pulmonary hypertension both clinically and experimentally. "( Effect of chlorphentermine on the pulmonary disposition of norepinephrine in the isolated perfused rabbit lung.
Angevine, LS; Ho, IK; Mehendale, HM; Nabeshima, T, 1981
)
1.13

Actions

Phentermine can produce clinically significant weight loss in women with obesity during the preconception period. Phentermine is thought to cause weight loss through a reduction in hunger.

ExcerptReferenceRelevance
"Phentermine can produce clinically significant weight loss in women with obesity during the preconception period. "( A Retrospective Study Examining Phentermine on Preconception Weight Loss and Pregnancy Outcomes.
Chang, JJ; Kim, SH; Lathi, RB, 2020
)
2.28
"Phentermine is thought to cause weight loss through a reduction in hunger. "( Greater hunger and less restraint predict weight loss success with phentermine treatment.
Bechtell, JL; Cornier, MA; Eckel, RH; Ferland, A; Mcnair, B; Thomas, EA, 2016
)
2.11
"Phentermine is known to cause valvular disease with prolonged use, but aortic valve rupture was not previously reported as a complication of phentermine valvulopathy."( Cusp tear in bicuspid aortic valve possibly caused by phentermine.
Beeri, R; Berman, M; Yosefy, C, 2006
)
1.3
"Phentermine also did not inhibit P450-2D6."( Appetite suppressant drugs as inhibitors of human cytochromes P450: in vitro inhibition of P450-2D6 by D- and L-fenfluramine, but not phentermine.
Ciraulo, DA; Duan, SX; Granda, BW; Grassi, JM; Greenblatt, DJ; Harmatz, JS; Shader, RI; von Moltke, LL, 1998
)
1.23

Treatment

Phentermine treatment does not induce phentermine drug craving, a hallmark sign of addiction. Treatment with Phentermine reduced the caloric intake by about 12% as compared with the ad libitum fed controls.

ExcerptReferenceRelevance
"Phentermine treatment does not induce phentermine drug craving, a hallmark sign of addiction."( Addiction potential of phentermine prescribed during long-term treatment of obesity.
De Marco, DG; Greenway, FL; Haggard, M; Hendricks, EJ; Hendricks, MJ; Istratiy, Y; Mitchell, CL; Schmidt, SL; Souter, S; Srisurapanont, M, 2014
)
1.43
"Treatment with phentermine reduced the caloric intake by about 12% as compared with the ad libitum fed controls."( Effects of phentermine and phenformin on biomarkers of aging in rats.
Anikin, IV; Anisimov, VN; Arutjunyan, AV; Bertsein, LM; Ingram, DK; Lane, MA; Popovich, IG; Roth, GS; Ukraintseva, SV; Zabezhinski, MA,
)
0.86
"Treatment with phentermine reduces caloric intake slightly less than is commonly observed in CR studies. "( Effects of phentermine and phenformin on biomarkers of aging in rats.
Anikin, IV; Anisimov, VN; Arutjunyan, AV; Bertsein, LM; Ingram, DK; Lane, MA; Popovich, IG; Roth, GS; Ukraintseva, SV; Zabezhinski, MA,
)
0.87

Toxicity

The study objective was to examine the association between phentermine/topiramate therapy and weight loss and adverse events in adults with overweight or obesity. Dry mouth and insomnia were the only statistically significant adverse events that occurred more frequently in the Phentermine group. None of the doses increased cardiovascular risk.

ExcerptReferenceRelevance
" PHEN also significantly enhanced FEN's long-term toxic effects on 5-HT axons."( Neurotoxic effects of +/-fenfluramine and phenteramine, alone and in combination, on monoamine neurons in the mouse brain.
McCann, UD; Ricaurte, GA; Yuan, J, 1998
)
0.3
" Receptorome screening has implicated N-deethylation of fenfluramine and serotonin 5-hydroxy-t-ryptamine 2B receptors in the adverse effects of the drug; subsequent studies corroborated this finding."( Screening the receptorome reveals molecular targets responsible for drug-induced side effects: focus on 'fen-phen'.
Roth, BL; Setola, V, 2005
)
0.33
" Dry mouth and insomnia were the only statistically significant adverse events that occurred more frequently in phentermine group."( Effects on weight reduction and safety of short-term phentermine administration in Korean obese people.
Cho, HJ; Kang, HC; Kim, KK; Lee, KR; Youn, BB, 2006
)
0.79
" However, in the existing studies PHEN/TPM ER had a superior weight loss profile to lorcaserin but the incidence of adverse effects was lower with lorcaserin."( Tolerability and safety of the new anti-obesity medications.
Aldhoon-Hainerová, I; Hainer, V, 2014
)
0.4
" Thus, if following the appropriate guidelines according to package labels, the practitioner can feel safe in prescribing these medications."( Safety and tolerability of medications approved for chronic weight management.
Fujioka, K, 2015
)
0.42
"To compare weight loss and adverse events among drug treatments for obesity using a systematic review and network meta-analysis."( Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis.
Camilleri, M; Chandar, AK; Dulai, PS; Khera, R; Loomba, R; Murad, MH; Prokop, LJ; Singh, S; Wang, Z, 2016
)
0.43
"Proportions of patients with at least 5% weight loss and at least 10% weight loss, magnitude of decrease in weight, and discontinuation of therapy because of adverse events at 1 year."( Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis.
Camilleri, M; Chandar, AK; Dulai, PS; Khera, R; Loomba, R; Murad, MH; Prokop, LJ; Singh, S; Wang, Z, 2016
)
0.43
"35) were associated with the highest odds of adverse event-related treatment discontinuation."( Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis.
Camilleri, M; Chandar, AK; Dulai, PS; Khera, R; Loomba, R; Murad, MH; Prokop, LJ; Singh, S; Wang, Z, 2016
)
0.43
" Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported."( Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.
Aronne, LJ; Fain, R; Fujioka, K; Garvey, WT; Greenway, FL; Pilson, R; Smith, SR; Zhou, S, 2017
)
0.73
"Over the past several decades, many antiobesity drugs have been withdrawn from the market due to unanticipated adverse events, often involving cardiotoxicity."( The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database.
Gorelik, B; Gorelik, E; Hirsh-Raccah, B; Masarwa, R; Matok, I; Perlman, A, 2020
)
0.56
"We used the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and retrieved data from January 2013 through December 2018."( The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database.
Gorelik, B; Gorelik, E; Hirsh-Raccah, B; Masarwa, R; Matok, I; Perlman, A, 2020
)
0.56
"During the evaluated period, a total of 6,787,840 adverse event reports were submitted to FAERS."( The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database.
Gorelik, B; Gorelik, E; Hirsh-Raccah, B; Masarwa, R; Matok, I; Perlman, A, 2020
)
0.56
" However, they are costly and may have adverse effects in some individuals."( Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand?
Lee, SY; Tak, YJ, 2021
)
0.62
"The study objective was to examine the association between phentermine/topiramate therapy and weight loss and adverse events in adults with overweight or obesity by meta-analysis and systematic review."( Efficacy and Safety of Phentermine/Topiramate in Adults with Overweight or Obesity: A Systematic Review and Meta-Analysis.
Lai, C; Lei, XG; Ruan, JQ; Sun, Z; Yang, X, 2021
)
1.18
" However, it increased the risk of nervous system-related adverse events."( Efficacy and Safety of Phentermine/Topiramate in Adults with Overweight or Obesity: A Systematic Review and Meta-Analysis.
Lai, C; Lei, XG; Ruan, JQ; Sun, Z; Yang, X, 2021
)
0.93
" None of the doses increased cardiovascular risk, although mild-to-moderate adverse events were more frequent with 30 mg phentermine."( Three- and six-month efficacy and safety of phentermine in a Mexican obese population.
Barranco-Garduño, LM; Carrasco-Portugal, MDC; Huerta-Cruz, JC; Kammar-García, A; Márquez-Cruz, M; Reyes-García, JG; Rocha González, HI; Rodríguez-Silverio, J, 2021
)
1.09
"0001), with similar serious adverse event rates (2."( Combining transoral outlet reduction with pharmacotherapy yields similar 1-year efficacy with improved safety compared with surgical revision for weight regain after Roux-en-Y gastric bypass (with videos).
Jirapinyo, P; Thompson, CC, 2023
)
0.91

Pharmacokinetics

This study assessed the potential pharmacokinetic interaction and safety/tolerability of taranabant and phentermine coadministration. The simple and robust LC/MS/MS method was successfully applied for the simultan.

ExcerptReferenceRelevance
" The 90% confidence intervals for the "test/reference" mean ratios of the pharmacokinetic variables Cmax,norm, Cmin,norm, AUCnorm (normalized for difference in the dose of phentermine base), %PTF and T75% Cmax, all fell within the bioequivalence range of 80% to 125%."( Steady-state pharmacokinetics of phentermine extended-release capsules.
Groenewoud, G; Hundt, HK; Müller, FO; Schall, R; van Dyk, M, 1993
)
0.76
" The method coupled with microdialysis was applied for a pharmacokinetic drug-drug interaction study of Phen and Fen following individual and combined intraperitoneal administration to rats."( Liquid chromatography studies on the pharmacokinetics of phentermine and fenfluramine in brain and blood microdialysates after intraperitoneal administration to rats.
Kaddoumi, A; Maki, T; Matsumura, Y; Nakamura, J; Nakashima, K; Nakashima, MN, 2003
)
0.56
"This study assessed the potential pharmacokinetic interaction and safety/tolerability of taranabant and phentermine coadministration."( Pharmacokinetics, safety, and tolerability of phentermine in healthy participants receiving taranabant, a novel cannabinoid-1 receptor (CB1R) inverse agonist.
Addy, C; Chodakewitz, J; Johnson-Levonas, AO; Jumes, P; Li, H; Li, S; Maes, A; Rosko, K; Stoch, SA; Wagner, JA, 2009
)
0.83
" The simple and robust LC/MS/MS method was successfully applied for the simultaneous determination of phentermine and topiramate in a pharmacokinetic study in healthy male Chinese volunteers."( Simultaneous determination of phentermine and topiramate in human plasma by liquid chromatography-tandem mass spectrometry with positive/negative ion-switching electrospray ionization and its application in pharmacokinetic study.
Chen, H; Haseeb, S; He, X; Li, H; Li, W; Ni, Y; Xu, M; Zhou, Y, 2015
)
0.92
" A pharmacokinetic curve for the incurred phentermine was successfully produced using the described validated method."( Hematocrit-Independent Quantitation of Stimulants in Dried Blood Spots: Pipet versus Microfluidic-Based Volumetric Sampling Coupled with Automated Flow-Through Desorption and Online Solid Phase Extraction-LC-MS/MS Bioanalysis.
Henion, J; Verplaetse, R, 2016
)
0.7
"To assess the pharmacokinetic (PK) and pharmacodynamic characteristics of VI-0521, a fixed-dose combination of immediate-release phentermine (PHEN) and extended-release topiramate (TPM) in adolescents aged 12 to 17 years with obesity, and to report weight loss and adverse events using this drug combination."( A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity.
Farhat, N; Gosselin, NH; Hsia, DS; Marier, JF; Peterson, C; Shih, W; Siegel, R; Williams, J, 2020
)
0.97
" So, we aimed to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) interactions of DWP16001 and phentermine."( Pharmacokinetic and pharmacodynamic interaction of DWP16001, a sodium-glucose cotransporter-2 inhibitor, with phentermine in healthy subjects.
Huh, W; Jin, BH; Kim, CO; Na, J; Park, MS; Shin, H; Yoon, S,
)
0.56

Compound-Compound Interactions

Phentermine combined with a meal replacement program and meal replacements alone significantly reduced body weight and food cravings. Lorcaserin in combination with phentermine improves control ofFood cravings during short-term energy restriction.

ExcerptReferenceRelevance
"In the 1990s, phentermine was combined with either fenfluramine or its active enantiomer dexfenfluramine to promote weight loss."( Effects of acute administration of phentermine, alone or in combination with dexfenfluramine, on pain reactivity in the adult rat.
Wellman, PJ, 2008
)
0.98
"To evaluate the long-term impact of Medifast meal-replacement supplements (MMRS) combined with appetite suppressant medication (ASM) among participants who received 52 weeks of treatment."( Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation.
DiBartolomeo, JJ; Foreyt, JP; Haddock, CK; Poston, WS; Warner, PO, 2008
)
0.35
"To examine the effects of phentermine combined with a meal replacement program on weight loss and food cravings and to investigate the relationship between food cravings and weight loss."( Effects of a meal replacement system alone or in combination with phentermine on weight loss and food cravings.
Aréchiga, AL; Bellinger, DL; Berk, LS; Daher, NS; Davis, WL; Hermé, AC; Moldovan, CP; Peters, WR; Schneider, LE; Weldon, AJ, 2016
)
0.97
"Both phentermine combined with a meal replacement program and meal replacements alone significantly reduced body weight and food cravings; however, the addition of phentermine enhanced these effects."( Effects of a meal replacement system alone or in combination with phentermine on weight loss and food cravings.
Aréchiga, AL; Bellinger, DL; Berk, LS; Daher, NS; Davis, WL; Hermé, AC; Moldovan, CP; Peters, WR; Schneider, LE; Weldon, AJ, 2016
)
1.19
"Lorcaserin in combination with phentermine improves control of food cravings during short-term energy restriction."( Effect of Lorcaserin Alone and in Combination with Phentermine on Food Cravings After 12-Week Treatment: A Randomized Substudy.
Aronne, LJ; Coulter, AA; Fujioka, K; Garvey, WT; Greenway, FL; Nikonova, EV; Rebello, CJ; Smith, SR; Zhou, S, 2018
)
1.02
" This use may also be associated with potential drug-drug interactions (PDDIs), which may result in adverse drug reactions (ADRs)."( Potential drug-drug interactions with phentermine among long-term phentermine consumers: A retrospective analysis.
Du Plessis, JM; Fourie, A; Julyan, M; Mostert, L, 2023
)
1.18

Bioavailability

ExcerptReferenceRelevance
" The hypothesis is proposed that this treatment is successful because of the dual and balanced increase in the bioavailability of the neurotransmitters, dopamine and serotonin, in the nucleus accumbens."( Combined dopamine and serotonin agonists: a synergistic approach to alcoholism and other addictive behaviors.
Hitzig, P, 1993
)
0.29
"Twenty-one healthy, caucasian, male volunteers completed this randomized single blind, multiple-dose, crossover bioavailability study during which either phentermine HCl capsules (Minobese Forte, reference product) or phentermine base capsules (Duromine, test product) were ingested once daily for 14 days."( Steady-state pharmacokinetics of phentermine extended-release capsules.
Groenewoud, G; Hundt, HK; Müller, FO; Schall, R; van Dyk, M, 1993
)
0.77

Dosage Studied

Phentermine has been considered a relatively safe drug to treat obesity. Further investigation is needed to decide the safety and dosage of Phentermine. Poor initial response to standard dosage of phentermine is unlikely to improve with higher dosage.

ExcerptRelevanceReference
" In addition, urinary and biliary metabolites of p-hydroxy-MP and p-hydroxy-Ph dosed orally to rat were examined."( Intestinal metabolism of mephentermine and its biliary metabolites in male Wistar rats.
Kobayashi, M; Kozuka, H; Miyahara, T; Mori, M; Uemura, H, 1992
)
0.58
" Dosing changes were based on an algorithm that aimed to achieve 120% of ideal body weight (IBW) while minimizing adverse effects."( Long-term weight control study. III (weeks 104 to 156). An open-label study of dose adjustment of fenfluramine and phentermine.
Moscucci, M; Schuster, B; Stein, EC; Sundaresan, PR; Weintraub, M, 1992
)
0.49
" p-Hydroxymephentermine (p-hydroxy-MP) and p-hydroxyphentermine (p-hydroxy-Ph) were isolated as hydrochlorides from urine of male Wistar rats repeatedly dosed with mephentermine (MP)."( Isolation of urinary p-hydroxylated metabolites of mephentermine and phentermine in male Wistar rats.
Inoue, M; Kozuka, H; Miyahara, T; Mori, MA; Sakai, K; Uy-Yu, N, 1990
)
0.91
" Poor initial response to standard dosage of phentermine is unlikely to improve with higher dosage."( Plasma phentermine levels, weight loss and side-effects.
Douglas, A; Douglas, JG; Munro, JF; Robertson, CE, 1983
)
0.98
" Treatment with the high dosage caused a significant reduction of creatinine clearance and significant impairment of both abilities to concentrate and to dilute the urine."( Impairment of renal function in rats with generalized lipidosis as induced by chlorphentermine.
Lüllmann, H; Lüllmann-Rauch, R; Mösinger, EU, 1981
)
0.49
" Mice were dosed daily (25 mg/kg po) for 28 days after which time carcass composition was determined."( The contribution of increased thermogenesis to the effect of anorectic drugs on body composition in mice.
Arch, JR, 1981
)
0.26
" Serial venous blood samples were drawn over the 24 hour dosing interval for plasma phentermine assay by gas chromatography."( Steady-state pharmacokinetics of phentermine extended-release capsules.
Groenewoud, G; Hundt, HK; Müller, FO; Schall, R; van Dyk, M, 1993
)
0.79
" Psychotic symptoms developed acutely after she increased the phentermine dosage to 150-180 mg/day for one month due to an increase in work load."( Schizophreniform-like psychotic disorder induced by phentermine: a case report.
Lee, SH; Liu, CY; Yang, YY, 1998
)
0.79
" Because many obese patients skip breakfast and eat more in the afternoon and evening, medication was dosed in order to cover these high-risk eating periods."( Lower dosages of phentermine-fenfluramine given in the afternoon: five cases with significant weight loss.
Katz, DA; Maloney, MJ; McConville, BJ; Sutkamp, JC, 1999
)
0.64
"To determine whether the severity of valvulopathy was associated with the dosage of fenfluramine taken by fenfluramine-phentermine users with valvulopathy."( Dose-effect of fenfluramine use on the severity of valvular heart disease among fen-phen patients with valvulopathy.
Bowman, BA; Graham, DJ; Green, L; Li, R; Serdula, MK; Williamson, DF, 1999
)
0.51
"The proportion with severe valvulopathy increased from 20-66% with increasing fenfluramine dosage from /=60 mg/d."( Dose-effect of fenfluramine use on the severity of valvular heart disease among fen-phen patients with valvulopathy.
Bowman, BA; Graham, DJ; Green, L; Li, R; Serdula, MK; Williamson, DF, 1999
)
0.3
" Doppler echocardiographic examination should be performed after prolonged exposure (> 3 months) or a high dosage of these drugs, in circumstances such as the presence of cardiovascular symptoms, a cardiac murmur, or an uncertain cardiac examination because of weight of patients."( [Appetite suppressants and heart valve disorders].
Adams, C; Cohen, A, 1999
)
0.3
" Phentermine has been considered a relatively safe drug to treat obesity, and further investigation is needed to decide the safety and dosage of phentermine."( Pulmonary hypertension associated with use of phentermine.
Bang, WD; Chang, HJ; Cho, SS; Jang, JY; Joung, B; Kim, JY; Oh, CM; Yu, HT, 2010
)
1.53
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" Off-label prescribing includes using medications for unapproved indications; using a drug outside of the recommended dosage range or duration of use; using a drug in certain unapproved patient populations, such as those defined by age, sex, or particular clinical parameters; or intentionally using a medication in a patient who has a known contraindication."( Off-label medication use.
Howland, RH, 2012
)
0.38
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (6)

RoleDescription
dopaminergic agentA drug used for its effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons.
adrenergic agentAny agent that acts on an adrenergic receptor or affects the life cycle of an adrenergic transmitter.
sympathomimetic agentA drug that mimics the effects of stimulating postganglionic adrenergic sympathetic nerves. Included in this class are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters.
appetite depressantAgent that is used to decrease appetite.
central nervous system stimulantAny drug that enhances the activity of the central nervous system.
central nervous system drugA class of drugs producing both physiological and psychological effects through a variety of mechanisms involving the central nervous system.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
primary amineA compound formally derived from ammonia by replacing one hydrogen atom by a hydrocarbyl group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (2)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
cytochrome P450 2D6Homo sapiens (human)Potency26.83700.00108.379861.1304AID1645840
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Trace amine-associated receptor 1Homo sapiens (human)EC50 (µMol)5.47000.01501.41437.1900AID341210
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (1)

Processvia Protein(s)Taxonomy
G protein-coupled receptor signaling pathwayTrace amine-associated receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (2)

Processvia Protein(s)Taxonomy
G protein-coupled receptor activityTrace amine-associated receptor 1Homo sapiens (human)
trace-amine receptor activityTrace amine-associated receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (1)

Processvia Protein(s)Taxonomy
plasma membraneTrace amine-associated receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (49)

Assay IDTitleYearJournalArticle
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1184074Solubility of the compound in pH 6.5 phosphate buffer containing 5% DMSO2014European journal of medicinal chemistry, Sep-12, Volume: 84Detailed analysis and follow-up studies of a high-throughput screening for indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678721Metabolic stability in human liver microsomes assessed as GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID341210Agonist activity at human trace amine associated receptor 1 expressed in RD-HGA16 CHO-K1 cells coexpressed with Galpha16 protein assessed as internal calcium mobilization by calcium 3 assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Structure-activity correlations for beta-phenethylamines at human trace amine receptor 1.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1184075Inhibition of IDO1 (unknown origin) at highest soluble concentration using L-tryptophan substrate incubated for 60 mins by HPLC2014European journal of medicinal chemistry, Sep-12, Volume: 84Detailed analysis and follow-up studies of a high-throughput screening for indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1184068Inhibition of IDO1 (unknown origin) using L-tryptophan substrate incubated for 60 mins by HPLC2014European journal of medicinal chemistry, Sep-12, Volume: 84Detailed analysis and follow-up studies of a high-throughput screening for indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID409943Inhibition of human recombinant MAOB by fluorimetric method2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID341211Agonist activity at human trace amine associated receptor 1 expressed in RD-HGA16 CHO-K1 cells coexpressed with Galpha16 protein assessed as internal calcium mobilization by calcium 3 assay relative to 2-phenylethanamine2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Structure-activity correlations for beta-phenethylamines at human trace amine receptor 1.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625278FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of no concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID588208Literature-mined public compounds from Lowe et al phospholipidosis modelling dataset2010Molecular pharmaceutics, Oct-04, Volume: 7, Issue:5
Predicting phospholipidosis using machine learning.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (801)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990267 (33.33)18.7374
1990's181 (22.60)18.2507
2000's122 (15.23)29.6817
2010's177 (22.10)24.3611
2020's54 (6.74)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 68.14

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index68.14 (24.57)
Research Supply Index6.86 (2.92)
Research Growth Index4.65 (4.65)
Search Engine Demand Index231.43 (26.88)
Search Engine Supply Index3.86 (0.95)

This Compound (68.14)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials82 (9.47%)5.53%
Reviews126 (14.55%)6.00%
Case Studies94 (10.85%)4.05%
Observational1 (0.12%)0.25%
Other563 (65.01%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (53)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effectiveness and Tolerability of Phentermine in the Reduction of Intrahepatic Fat Infiltration, Adipose Tissue and Postoperative Complications in Patients Under Bariatric Surgery [NCT03849729]Phase 492 participants (Actual)Interventional2018-03-01Completed
A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents [NCT02714062]Phase 442 participants (Actual)Interventional2016-03-31Completed
Long-term Effectiveness of the Antiobesity Medication Phentermine [NCT05176626]Phase 41,000 participants (Anticipated)Interventional2022-06-30Recruiting
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker. [NCT04408586]Phase 480 participants (Actual)Interventional2020-06-03Completed
A Multicenter, Randomized, Double-Blind Study to Compare the Effects of VI-0521,Phentermine, and Placebo on Ambulatory Blood Pressure in Overweight or Obese Subjects [NCT05215418]Phase 4567 participants (Actual)Interventional2022-01-25Completed
SMART Use of Medication for the Treatment of Adolescent Severe Obesity [NCT04007393]Phase 2150 participants (Anticipated)Interventional2019-11-21Active, not recruiting
The Effects of Orlistat/Phentermine Versus Placebo/Phentermine Treatment on Weight Loss and Vascular Function of Overweight Patients With Back Pain [NCT03675191]114 participants (Actual)Interventional2018-10-16Completed
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity [NCT04298203]Phase 2143 participants (Anticipated)Interventional2021-08-04Recruiting
Clinical Evaluation of an Specific Diet for People With Dementia Disease [NCT01192529]184 participants (Anticipated)Interventional2010-10-31Recruiting
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity [NCT04881799]Early Phase 130 participants (Anticipated)Interventional2022-07-07Recruiting
The Use of a Virtual Weight Management Program for Prescription of Phentermine in Patients With Overweight or Obesity Compared to Standard Face to Face Visits [NCT04614545]Phase 470 participants (Actual)Interventional2021-01-01Completed
Topiramate-Phentermine Combinations for Cocaine Dependence [NCT02239913]Phase 138 participants (Actual)Interventional2014-09-30Completed
A Phase I, Open Label, Single-Dose Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment and In Healthy Control Subjects [NCT00768209]Phase 118 participants (Actual)Interventional2008-10-31Completed
Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation? [NCT00771654]0 participants (Actual)Interventional2009-02-28Withdrawn(stopped due to Low enrollment)
A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents [NCT03922945]Phase 4223 participants (Actual)Interventional2019-05-02Completed
A Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Istradefylline in Recreational Drug Users [NCT02609477]Phase 142 participants (Actual)Interventional2016-01-31Completed
A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults [NCT00600067]Phase 2130 participants (Actual)Interventional2008-01-31Completed
A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults [NCT00563368]Phase 3756 participants (Actual)Interventional2007-12-31Completed
Long-term Phentermine Pharmacotherapy: An Investigation for Symptoms of Dependence, Cravings, or Withdrawal [NCT01402674]269 participants (Actual)Interventional2011-08-31Completed
Qsymia (Phentermine-topiramate) to Reduce Binge Eating/Purging in Patients With Bulimia Nervosa and Binge Eating Disorder [NCT02553824]Phase 122 participants (Actual)Interventional2015-10-30Completed
A Phase I, Open-Label, Parallel-Group, Single Dose, Non-Randomized Study To Compare The Pharmacokinetics Of Each Individual Component (Topiramate And Phentermine) Of The Combination Product VI-0521 In Subjects With Mild, Moderate And Severe Renal Impairme [NCT00768404]Phase 132 participants (Actual)Interventional2008-10-31Completed
A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users [NCT01500018]Phase 10 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to Sponsor decision to withdraw.)
Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study [NCT04095104]Phase 213 participants (Actual)Interventional2020-01-15Completed
An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial [NCT04531176]Phase 469 participants (Actual)Interventional2020-09-01Active, not recruiting
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial [NCT04721873]Phase 240 participants (Anticipated)Interventional2020-12-18Recruiting
Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss [NCT05139420]60 participants (Anticipated)Interventional2022-09-10Active, not recruiting
Combining Lifestyle Modification and Liraglutide to Improve Weight Loss and Health Outcomes [NCT02911818]Phase 4150 participants (Actual)Interventional2016-09-30Completed
Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study [NCT01247714]43 participants (Actual)Interventional2009-09-30Active, not recruiting
A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults [NCT00518466]Phase 164 participants (Actual)Interventional2007-07-31Completed
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery [NCT05975580]Phase 4120 participants (Anticipated)Interventional2023-08-29Recruiting
Comparison of Dapagliflozin (DAPA) and Once-weekly Exenatide (EQW), Co-administered or Alone, DAPA/ Glucophage (DAPA/MET ER) and Phentermine/Topiramate (PHEN/TPM) ER on Metabolic Profiles and Body Composition in Obese PCOS Women [NCT02635386]Phase 3119 participants (Actual)Interventional2016-03-22Completed
Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study) [NCT05590624]30 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects [NCT00402077]Phase 2258 participants (Actual)Interventional2006-11-30Completed
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Qsymia in Obese Patients [NCT05378503]Phase 4301 participants (Anticipated)Interventional2021-09-17Recruiting
A Randomized, Double-Blind, Active- and Placebo-Controlled, Single-Dummy, 4-Way Crossover Study to Determine the Abuse Potential of Pitolisant Compared to Phentermine and Placebo, in Healthy, Non-Dependent Recreational Stimulant Users [NCT03152123]Phase 143 participants (Actual)Interventional2017-03-15Completed
Use of Pharmacotherapy to Improve Weight Loss in Early Non-responders to Behavioral Treatment [NCT03779048]Phase 4147 participants (Actual)Interventional2019-07-15Completed
The Quantification of Ingestive Behavior [NCT01886937]Phase 413 participants (Actual)Interventional2012-07-31Completed
Effect of Caloric Restriction on Metabolic Biomarkers and Fat Oxidation in Obese Men and Women (Magellan II) [NCT01616082]39 participants (Actual)Interventional2011-09-30Completed
Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients [NCT01834404]Phase 424 participants (Actual)Interventional2013-04-30Completed
A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population [NCT01719185]Early Phase 122 participants (Actual)Interventional2012-09-30Completed
The Mechanism of Human Non-Shivering Thermogenesis and Basal Metabolic Rate [NCT01950520]Phase 2134 participants (Anticipated)Interventional2014-02-07Recruiting
A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population With BMI ≥ 35 [NCT00554216]Phase 31,267 participants (Actual)Interventional2007-11-30Completed
Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial [NCT03374956]Phase 3193 participants (Actual)Interventional2017-12-11Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese [NCT02243202]Phase 2335 participants (Actual)Interventional2014-09-30Completed
[NCT00000506]Phase 20 participants Interventional1983-05-31Completed
Qsymia as an Adjunct to Surgical Therapy in the Superobese [NCT02301416]Phase 225 participants (Actual)Interventional2014-12-31Completed
Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study [NCT04572217]Phase 20 participants (Actual)Interventional2022-06-30Withdrawn(stopped due to No available funding)
A Toolbox Approach to Obesity Treatment in Primary Care [NCT01922934]Phase 44,730 participants (Actual)Interventional2014-01-31Completed
Phentermine/tOpiramate to eND Obesity and Uric Acid Stones Trial (POuND OUT) [NCT04621929]Phase 340 participants (Anticipated)Interventional2021-03-31Recruiting
A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Ob [NCT01987427]Phase 4344 participants (Actual)Interventional2013-10-30Completed
A Phase IV, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of VI-0521 on the Glomerular Filtration Rate of Healthy Overweight or Obese Subjects [NCT02229214]Phase 451 participants (Actual)Interventional2014-08-31Completed
Effectiveness of Semaglutide 2.4 mg vs. Commercially Available Medications for Chronic Weight Management in Participants With Obesity in a Multi-employer Setting in The US - a Pragmatic Clinical Study [NCT05579249]Phase 4500 participants (Anticipated)Interventional2023-01-19Recruiting
Pilot Study of the Effect of Weight Loss by Pharmacotherapy on Chronic Pro-tumor Inflammatory Cells [NCT05756764]24 participants (Anticipated)Observational2023-05-23Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00554216 (2) [back to overview]Percentage of Subjects With at Least 5% Weight Loss at Week 56
NCT00554216 (2) [back to overview]Percent Weight Loss From Baseline to Week 56
NCT00563368 (2) [back to overview]Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
NCT00563368 (2) [back to overview]Percent Weight Loss From Baseline to Week 28
NCT00600067 (2) [back to overview]Percent Weight Loss From Baseline to Week 56
NCT00600067 (2) [back to overview]HbA1c Change From Baseline Week 0 to Week 56
NCT01616082 (3) [back to overview]Fat Oxidation Rates at 1 Week Intervals
NCT01616082 (3) [back to overview]Change From Baseline Amount of Fat Oxidation at 14 Days
NCT01616082 (3) [back to overview]Soleus IMCL Content
NCT01834404 (13) [back to overview]Solid Gastric Emptying: Proportion Remaining at 4 Hours
NCT01834404 (13) [back to overview]Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours
NCT01834404 (13) [back to overview]Postprandial Gastric Volume
NCT01834404 (13) [back to overview]Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)
NCT01834404 (13) [back to overview]Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)
NCT01834404 (13) [back to overview]Volume to Fullness
NCT01834404 (13) [back to overview]Maximum Tolerated Volume
NCT01834404 (13) [back to overview]Gastric Emptying of Solids Half-Time (T 1/2)
NCT01834404 (13) [back to overview]Peak Postprandial Level of Cholecystokinin (CCK)
NCT01834404 (13) [back to overview]Buffet Meal Intake
NCT01834404 (13) [back to overview]Change in Postprandial Gastric Volume
NCT01834404 (13) [back to overview]Fasting Gastric Volume
NCT01834404 (13) [back to overview]Fasting Ghrelin
NCT01886937 (1) [back to overview]Food Intake
NCT01922934 (4) [back to overview]Documentation of Obesity
NCT01922934 (4) [back to overview]Health Care Utilization - Laboratory Measurements
NCT01922934 (4) [back to overview]Percentage of Participants Who Achieved >5% Weight Loss at 12 Months
NCT01922934 (4) [back to overview]Health Care Utilization - Non-study Clinic Visits
NCT01987427 (8) [back to overview]Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation
NCT01987427 (8) [back to overview]Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
NCT01987427 (8) [back to overview]Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
NCT01987427 (8) [back to overview]Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
NCT01987427 (8) [back to overview]Change From Baseline in Waist Circumference and Hip Circumference at Week 12
NCT01987427 (8) [back to overview]Percentage of Participants Who Achieved Greater Than or Equal to (>=) 5 Percent (%) Weight Reduction at Week 12
NCT01987427 (8) [back to overview]Percentage of Participants Reporting at Least One of Nine Adverse Events (AEs) of Main Interests That May Related to Serotonergic Reaction
NCT01987427 (8) [back to overview]Change From Baseline in Waist to Hip Circumference Ratio at Week 12
NCT02229214 (8) [back to overview]Change in Cystatin C From Baseline to End of Treatment
NCT02229214 (8) [back to overview]Change in Cystatin C From Baseline to 28 Days After End of Treatment
NCT02229214 (8) [back to overview]Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment
NCT02229214 (8) [back to overview]Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment
NCT02229214 (8) [back to overview]Change in Serum Creatinine From Baseline to End of Treatment
NCT02229214 (8) [back to overview]Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment
NCT02229214 (8) [back to overview]Change in Serum Creatinine From Baseline to 28 Days After End of Treatment
NCT02229214 (8) [back to overview]Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment
NCT02243202 (7) [back to overview]Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
NCT02243202 (7) [back to overview]Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
NCT02243202 (7) [back to overview]Percent Change From Baseline in Body Weight at Week 26
NCT02243202 (7) [back to overview]Change From Baseline in Systolic Blood Pressure at Week 26
NCT02243202 (7) [back to overview]Change From Baseline in Pulse Rate at Week 26
NCT02243202 (7) [back to overview]Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
NCT02243202 (7) [back to overview]Absolute Change From Baseline in Body Weight at Week 26
NCT02301416 (9) [back to overview]Percent Weight Change
NCT02301416 (9) [back to overview]Percent Weight Change
NCT02301416 (9) [back to overview]Body Mass Index
NCT02301416 (9) [back to overview]Body Mass Index
NCT02301416 (9) [back to overview]Body Mass Index
NCT02301416 (9) [back to overview]Body Mass Index
NCT02301416 (9) [back to overview]Percent Weight Change
NCT02301416 (9) [back to overview]Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)
NCT02301416 (9) [back to overview]Percent Weight Change
NCT02635386 (23) [back to overview]Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
NCT02635386 (23) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Levels
NCT02635386 (23) [back to overview]Diastolic Blood Pressure (DBP)
NCT02635386 (23) [back to overview]Fasting Blood Glucose
NCT02635386 (23) [back to overview]Fasting Insulin Sensitivity (HOMA-IR)
NCT02635386 (23) [back to overview]Free Androgen Index (FAI)
NCT02635386 (23) [back to overview]Matsuda Sensitivity Index Derived From the OGTT(SI OGTT)
NCT02635386 (23) [back to overview]OGTT Mean Blood Glucose (MBG)
NCT02635386 (23) [back to overview]Oral Disposition (Insulin Sensitivity-insulin Secretion) Index
NCT02635386 (23) [back to overview]Systolic Blood Pressure (SBP)
NCT02635386 (23) [back to overview]Total Body Fat (%) by DEXA
NCT02635386 (23) [back to overview]Total Cholesterol Levels
NCT02635386 (23) [back to overview]Total Fat Mass (kg) Evaluated by DEXA
NCT02635386 (23) [back to overview]Total Testosterone Concentrations
NCT02635386 (23) [back to overview]Triglyceride (TRG) Levels
NCT02635386 (23) [back to overview]Trunk/Leg Fat Ratio by DEXA
NCT02635386 (23) [back to overview]Waist-to-Hip Ratio (WHR)
NCT02635386 (23) [back to overview]Body Mass Index (BMI)
NCT02635386 (23) [back to overview]Absolute Body Weight
NCT02635386 (23) [back to overview]Android-Gynoid Ratio (AGR) as Determined by DEXA
NCT02635386 (23) [back to overview]Waist-to-Height Ratio (WHtR)
NCT02635386 (23) [back to overview]Central Adiposity (Waist Circumference)
NCT02635386 (23) [back to overview]Change in Percent Body Weight
NCT02714062 (15) [back to overview]Change in HOMA-IR
NCT02714062 (15) [back to overview]Change in Visual Analog Scale (VAS) Hunger Scores
NCT02714062 (15) [back to overview]Change in Visual Analog Scale (VAS) Satiety Scores
NCT02714062 (15) [back to overview]Change in Waist Circumference
NCT02714062 (15) [back to overview]Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)
NCT02714062 (15) [back to overview]Weight Loss
NCT02714062 (15) [back to overview]Apparent Clearance (CL/F) of Phentermine and Topiramate
NCT02714062 (15) [back to overview]Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
NCT02714062 (15) [back to overview]Area Under the Curve (AUC) of Phentermine
NCT02714062 (15) [back to overview]Area Under the Curve (AUC) of Topiramate
NCT02714062 (15) [back to overview]Change in Blood Pressure
NCT02714062 (15) [back to overview]Change in Lipid Parameters
NCT02714062 (15) [back to overview]Change in OGTT of Fasting and 2-hour Glucose
NCT02714062 (15) [back to overview]Maximum Concentration (Cmax) of Phentermine
NCT02714062 (15) [back to overview]Maximum Concentration (Cmax) of Topiramate
NCT02911818 (34) [back to overview]Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary
NCT02911818 (34) [back to overview]Change 36-Item Short Form Survey (SF-36) - Mental Component Summary
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in c-Reactive Protein
NCT02911818 (34) [back to overview]Percent Change in Baseline Weight
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: SF-36 - Physical Health Component
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: SF-36 - Mental Health Component
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Waist Circumference
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Triglycerides
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Total Cholesterol
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Systolic Blood Pressure
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in LDL Cholesterol
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in HOMA-IR
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Heart Rate
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in HDL Cholesterol
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in HbA1c
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Fasting Insulin
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Fasting Glucose
NCT02911818 (34) [back to overview]Extension Study Secondary Outcome: Change in Diastolic Blood Pressure
NCT02911818 (34) [back to overview]Extension Study Primary Outcome: Percent Change in Re-randomization Weight
NCT02911818 (34) [back to overview]Change in Waist Circumference
NCT02911818 (34) [back to overview]Change in Triglycerides
NCT02911818 (34) [back to overview]Change in Total Cholesterol
NCT02911818 (34) [back to overview]Change in Fasting Insulin
NCT02911818 (34) [back to overview]Change in Systolic Blood Pressure
NCT02911818 (34) [back to overview]Change in Patient Health Questionnaire (PHQ-9)
NCT02911818 (34) [back to overview]Change in LDL Cholesterol
NCT02911818 (34) [back to overview]Change in HOMA-IR
NCT02911818 (34) [back to overview]Change in Heart Rate
NCT02911818 (34) [back to overview]Change in HDL Cholesterol
NCT02911818 (34) [back to overview]Change in HbA1c
NCT02911818 (34) [back to overview]Change in Fasting Glucose
NCT02911818 (34) [back to overview]Change in Diastolic Blood Pressure
NCT02911818 (34) [back to overview]Change in C Reactive Protein
NCT03374956 (3) [back to overview]Percentage of Responders
NCT03374956 (3) [back to overview]Percentage of Responders
NCT03374956 (3) [back to overview]Change in Total Body Weight
NCT03922945 (11) [back to overview]Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56
NCT03922945 (11) [back to overview]Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56
NCT03922945 (11) [back to overview]Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56
NCT03922945 (11) [back to overview]Percent Change in HDL-C From Baseline to Week 56
NCT03922945 (11) [back to overview]Mean % Change in Body Mass Index (BMI)
NCT03922945 (11) [back to overview]Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56
NCT03922945 (11) [back to overview]Change in Waist Circumference at Week 56
NCT03922945 (11) [back to overview]Change in Fasting Insulin at Week 56
NCT03922945 (11) [back to overview]Change From Baseline in Systolic Blood Pressure at Week 56
NCT03922945 (11) [back to overview]Change From Baseline in Diastolic Blood Pressure at Week 56
NCT03922945 (11) [back to overview]Percent Change in Triglycerides From Baseline to Week 56
NCT04408586 (8) [back to overview]Body Weight Change
NCT04408586 (8) [back to overview]Body Weight Change
NCT04408586 (8) [back to overview]Change in SF-12 Physical Score (Health-related Quality Quality of Life)
NCT04408586 (8) [back to overview]Tracker Usage
NCT04408586 (8) [back to overview]Exercise Sessions
NCT04408586 (8) [back to overview]Change in Step Count
NCT04408586 (8) [back to overview]Change in SF-12 Mental Score (Health-related Quality Quality of Life)
NCT04408586 (8) [back to overview]Change in Calories
NCT04614545 (5) [back to overview]Percentage of Patients Who Achieved More Than 5% Weight Loss Over the Course of the Study (12 Weeks)
NCT04614545 (5) [back to overview]Change in Body Weight (Percentage)
NCT04614545 (5) [back to overview]Adherence to Weight Management Program
NCT04614545 (5) [back to overview]Adherence to Medication Use
NCT04614545 (5) [back to overview]Percentage of Patients That Tolerated Full Dosage of Phentermine (37.5mg)

Percentage of Subjects With at Least 5% Weight Loss at Week 56

(NCT00554216)
Timeframe: baseline to 56 weeks

Interventionpercentage of participants (Number)
Placebo17.3
VI-0521 Low44.9
VI-0521 Top66.7

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Percent Weight Loss From Baseline to Week 56

(NCT00554216)
Timeframe: baseline to 56 weeks

Interventionpercent weight loss (Least Squares Mean)
Placebo1.55
VI-0521 Low5.10
VI-0521 Top10.92

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Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF

(NCT00563368)
Timeframe: baseline to 28 weeks

Interventionpercentage of participants (Number)
Placebo15.5
PHEN 7.5 mg43.3
TPM 46 mg39.2
VI-0521 Mid62.1
PHEN 15 mg46.2
TPM 92 mg48.6
VI-0521 Top66.0

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Percent Weight Loss From Baseline to Week 28

Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF) (NCT00563368)
Timeframe: baseline to 28 weeks

Interventionpercent weight loss (Least Squares Mean)
Placebo1.7
PHEN 7.5 mg5.5
TPM 46 mg5.1
VI-0521 Mid8.5
PHEN 15 mg6.1
TPM 92 mg6.4
VI-0521 Top9.2

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Percent Weight Loss From Baseline to Week 56

(NCT00600067)
Timeframe: Baseline to 56 weeks

Interventionpercent change (Least Squares Mean)
Placebo-2.71
VI-0521-9.41

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HbA1c Change From Baseline Week 0 to Week 56

(NCT00600067)
Timeframe: Baseline to 56 weeks

Interventionpercent change (Least Squares Mean)
Placebo-1.2
VI-0521-1.56

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Fat Oxidation Rates at 1 Week Intervals

"Measured with respiratory quotient using indirect calorimetry~Expected Results~Overweight and obese subjects will show a wide variation in fat oxidation in response to the low calorie diet~Approximately one-third of study participants will not meet target weight loss by four weeks~Following an overnight fast (prior to and during LCD) individuals that fail to meet the target weight loss will be charaterized by decreased whole body fat oxidation and increased carbohydrate oxidation (measured by indirect calorimetry)" (NCT01616082)
Timeframe: Days 0, 7, 14, 28, 49, 56

,
InterventionRatio (Mean)
Day 0Day 7Day 14Day 28Day 49Day 56
Overweight/ Obese With no Drug0.8670.7950.7910.8080.8000.798
Overweight/ Obese With Phentermine0.8570.7870.8010.8110.7840.785

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Change From Baseline Amount of Fat Oxidation at 14 Days

"Measured with respiratory quotient obtained with indirect calorimetry~Expected Results~Overweight and obese subjects will show a wide variation in fat oxidation in response to the low calorie diet~Approximately one-third of study participants will not meet target weight loss by four weeks~Following an overnight fast (prior to and during LCD) individuals that fail to meet the target weight loss will be characterized by decreased whole body fat oxidation and increased carbohydrate oxidation (measured by indirect calorimetry)" (NCT01616082)
Timeframe: Days 0, 14

InterventionFold change of RQ ratio (Mean)
Overweight/Obese With no Drug0.91
Overweight/ Obese With Phentermine0.94

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Soleus IMCL Content

"Measured with magnetic resonance spectroscopy (MRS)~Expected results~1H-MRS can measure skeletal muscle (intramyocellular lipid) IMCL content with low test-retest variability~1H-MRS can sensitively monitor reductions (or lack thereof) in skeletal muscle IMCL during caloric restriction~Reductions in IMCL will be higher in subjects with lower fasting respiratory quotients (RQ) at baseline/during LCD" (NCT01616082)
Timeframe: Days -7, -1, 14, 56

,
Interventionratio of peak height of IMCL to water (Mean)
Day -7Day 0Day 14Day 56
Overweight/ Obese With no Drug0.0250.0280.0300.027
Overweight/ Obese With Phentermine0.0320.0340.0340.034

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Solid Gastric Emptying: Proportion Remaining at 4 Hours

At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal remaining at 4 hours. (NCT01834404)
Timeframe: Day 15, approximately 4 hours after radiolabeled meal was ingested

Interventionproportion of meal remaining (Least Squares Mean)
Phentermine-Topiramate ER0.09
Placebo0.16

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Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours

At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours. (NCT01834404)
Timeframe: Day 15, approximately 2 hours after radiolabeled meal was ingested

Interventionproportion of meal emptied (Least Squares Mean)
Phentermine-Topiramate ER0.56
Placebo0.66

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Postprandial Gastric Volume

Postprandial gastric volume was measured by 99mTc-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. After the liquid meal tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. (NCT01834404)
Timeframe: Day 13, approximately 30 minutes after liquid meal

InterventionmL (Mean)
Phentermine-Topiramate ER680
Placebo681

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Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)

Plasma gastrointestinal hormone PYY was measured by radioimmunoassay. (NCT01834404)
Timeframe: Day 14, approximately 45 minutes after liquid meal

Interventionpg/mL (Mean)
Phentermine-Topiramate ER195.3
Placebo166

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Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)

Plasma gastrointestinal hormone GLP-1 was measured by radioimmunoassay. (NCT01834404)
Timeframe: Day 14, approximately 45 minutes after liquid meal

Interventionpg/mL (Mean)
Phentermine-Topiramate ER13.0
Placebo11.9

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Volume to Fullness

At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3. (NCT01834404)
Timeframe: Day 14, approximately 30 minutes after liquid meal

InterventionmL (Mean)
Phentermine-Topiramate ER570
Placebo630

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Maximum Tolerated Volume

At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reached level 5. (NCT01834404)
Timeframe: Day 14, approximately 30 minutes after liquid meal

InterventionmL (Mean)
Phentermine-Topiramate ER966
Placebo1108

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Gastric Emptying of Solids Half-Time (T 1/2)

Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. (NCT01834404)
Timeframe: Day 15, approximately 2 hours after radiolabeled meal was ingested

Interventionminutes (Mean)
Phentermine-Topiramate ER109
Placebo88

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Peak Postprandial Level of Cholecystokinin (CCK)

Plasma gastrointestinal hormone CCK was measured by radioimmunoassay based on an antibody with very low cross-reactivity to gastrin 17 and its sulfated counterpart, and to sensitivity to a concentration of 0.3 pmol/L. (NCT01834404)
Timeframe: Day 14, approximately 45 minutes after liquid meal

Interventionpg/mL (Mean)
Phentermine-Topiramate ER8.1
Placebo8.3

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Buffet Meal Intake

"At visit 4 subjects underwent imaging to measure the volume of their stomach, fasting and after ingesting a liquid nutrient drink. Four hours after the liquid meal, subjects were invited to eat, over a 30-minute period, a standard all you can eat meal vegetable lasagna, vanilla pudding, and skim milk. The total Kcal of the food consumed was analyzed by using validated software." (NCT01834404)
Timeframe: Day 13, approximately 4.5 hours after liquid meal

InterventionKcal (Mean)
Phentermine-Topiramate ER728
Placebo988

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Change in Postprandial Gastric Volume

Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. (NCT01834404)
Timeframe: Day 13, approximately approximately 30 min after liquid meal

InterventionmL (Least Squares Mean)
Phentermine-Topiramate ER453
Placebo420

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Fasting Gastric Volume

Fasting whole gastric volume was measured by Technetium (99mTc)-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. (NCT01834404)
Timeframe: Day 13, approximately 10 minutes after Technetium (99mTC) injection

InterventionmL (Mean)
Phentermine-Topiramate ER227
Placebo261

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Fasting Ghrelin

Plasma gastrointestinal hormone total ghrelin was measured by radioimmunoassay. (NCT01834404)
Timeframe: Day 14, before liquid meal

Interventionpg/mL (Mean)
Phentermine-Topiramate ER78.1
Placebo82.6

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Food Intake

The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration. (NCT01886937)
Timeframe: one week

Interventionkcal (Mean)
37.5 mg Phentermine Daily for 7 Days849
Placebo (for Phentermine 37.5mg)975

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Documentation of Obesity

"To assess:~Presence of ICD-9 code for obesity in the DHHA registry Control Group~Evidence of a specific intervention for weight management resembling what was offered in the toolbox intervention: weight loss medication prescribed, gym membership, weight loss program or referral to wt loss specialist, and meal replacements" (NCT01922934)
Timeframe: 1 year study period

InterventionParticipants (Count of Participants)
ICD-Code for Obesity in Chart72219847Specific Intervention provided72219847
AbsentPresent
Random Sample of DHHA Registry Control Group52
Random Sample of DHHA Registry Control Group68
Random Sample of DHHA Registry Control Group14
Random Sample of DHHA Registry Control Group106

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Health Care Utilization - Laboratory Measurements

Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of number of lab measurements taken during the period (including A1C, creatinine, and lipids). (NCT01922934)
Timeframe: 1 year study period

,
InterventionNumber of measurements (Least Squares Mean)
A1C measurementsCreatinine measurementsLipid measurements
Intervention Group1.192.170.45
Registry-Based Control Group1.192.200.41

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Percentage of Participants Who Achieved >5% Weight Loss at 12 Months

Participants who had both a baseline and 12 month weight measurement were included. Weight change at 12 months was measured as a percent difference from their starting weight. (NCT01922934)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Intervention Group34.5
Registry-Based Control Group15.7

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Health Care Utilization - Non-study Clinic Visits

Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of non-study clinic visits. (NCT01922934)
Timeframe: 1 year study period

InterventionNumber of visits (Least Squares Mean)
Intervention Group4.44
Registry-Based Control Group4.32

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Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation

(NCT01987427)
Timeframe: Baseline up to Week 16

,,
InterventionParticipants (Count of Participants)
TEAESAEAEs leading to study drug discontinuation
Lorcaserin 10 mg BID + Phentermine 15 mg BID5419
Lorcaserin 10 mg BID + Phentermine Placebo BID5004
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD5222

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Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12

(NCT01987427)
Timeframe: Baseline, Weeks 1, 2, 4, 8 and 12

,,
Interventionkilogram (kg) (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Lorcaserin 10 mg BID + Phentermine 15 mg BID106.63-1.97-2.94-4.44-6.33-7.55
Lorcaserin 10 mg BID + Phentermine Placebo BID105.33-0.94-1.56-2.27-2.87-3.48
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD105.04-1.36-2.43-3.81-5.76-7.00

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Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12

(NCT01987427)
Timeframe: Baseline, Weeks 1, 2, 4, 8 and 12

,,
Interventionpercent change (Mean)
Week 1Week 2Week 4Week 8Week 12
Lorcaserin 10 mg BID + Phentermine 15 mg BID-1.82-2.75-4.20-6.03-7.23
Lorcaserin 10 mg BID + Phentermine Placebo BID-0.93-1.47-2.18-2.77-3.29
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD-1.28-2.33-3.68-5.54-6.69

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Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values

(NCT01987427)
Timeframe: Baseline up to Week 16

,,
InterventionParticipants (Count of Participants)
Gamma glutamyl transferase: highPhosphorus: lowPotassium: highTotal bilirubin: highTriglycerides: HighUric acid: highHemoglobin: lowLymphocytes: highNeutrophils: lowWhite blood cell (WBC) count: low
Lorcaserin 10 mg BID + Phentermine 15 mg BID1010000101
Lorcaserin 10 mg BID + Phentermine Placebo BID0010011020
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD1131101010

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Change From Baseline in Waist Circumference and Hip Circumference at Week 12

(NCT01987427)
Timeframe: Baseline and Week 12 (end of treatment)

,,
Interventioncentimeter (cm) (Mean)
Waist Circumference: BaselineWaist Circumference: Change at Week 12Hip Circumference: BaselineHip Circumference: Change at Week 12
Lorcaserin 10 mg BID + Phentermine 15 mg BID114.0-7.1125.4-6.2
Lorcaserin 10 mg BID + Phentermine Placebo BID112.2-3.4124.1-2.8
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD112.2-4.7123.7-3.6

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Percentage of Participants Who Achieved Greater Than or Equal to (>=) 5 Percent (%) Weight Reduction at Week 12

(NCT01987427)
Timeframe: Week 12 (end of treatment)

Interventionpercentage of participants (Number)
Lorcaserin 10 mg BID + Phentermine Placebo BID28.2
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD59.0
Lorcaserin 10 mg BID + Phentermine 15 mg BID70.9

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Change From Baseline in Waist to Hip Circumference Ratio at Week 12

(NCT01987427)
Timeframe: Baseline and Week 12 (end of treatment)

,,
Interventionratio (Mean)
BaselineChange at Week 12
Lorcaserin 10 mg BID + Phentermine 15 mg BID0.91-0.01
Lorcaserin 10 mg BID + Phentermine Placebo BID0.91-0.01
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD0.91-0.01

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Change in Cystatin C From Baseline to End of Treatment

(NCT02229214)
Timeframe: Baseline, end of treatment

Interventionmg/L (Mean)
VI-0521 (Qsymia)0.04
Placebo0.03

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Change in Cystatin C From Baseline to 28 Days After End of Treatment

(NCT02229214)
Timeframe: Baseline, 28 days after end of treatment

Interventionmg/L (Mean)
VI-0521 (Qsymia)0.01
Placebo0.02

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Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment

"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR" (NCT02229214)
Timeframe: Baseline, 28 days after end of treatment

InterventionmL/min/1.73 m^2 (Mean)
VI-0521 (Qsymia)-3.75
Sugar Pill2.34

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Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment

(NCT02229214)
Timeframe: Baseline, 28 days after end of treatment

Interventionpercent of participants (Number)
VI-0521 (Qsymia)7.3
Placebo0

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Change in Serum Creatinine From Baseline to End of Treatment

(NCT02229214)
Timeframe: Baseline, end of treatment

Interventionmg/dL (Mean)
VI-0521 (Qsymia)0.10
Sugar Pill0.03

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Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment

(NCT02229214)
Timeframe: Baseline, end of treatment

Interventionpercent of participants (Number)
VI-0521 (Qsymia)48.8
Placebo0

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Change in Serum Creatinine From Baseline to 28 Days After End of Treatment

(NCT02229214)
Timeframe: Baseline, 28 days after end of treatment

Interventionmg/dL (Mean)
VI-0521 (Qsymia)-0.01
Sugar Pill0.03

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Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment

"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR." (NCT02229214)
Timeframe: Baseline, end of treatment

InterventionmL/min/1.73 m^2 (Mean)
VI-0521 (Qsymia)-14.92
Placebo1.08

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Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26

Percentage of participants with weight loss >= 5 percent were analysed at week 26. (NCT02243202)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Placebo17.5
Phentermine 15 mg41.7
Canagliflozin 300 mg17.9
Canagliflozin 300 mg/Phentermine 15 mg66.7

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Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26

Percentage of participants with weight loss >= 10 percent at week 26. (NCT02243202)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
Placebo8.8
Phentermine 15 mg8.3
Canagliflozin 300 mg5.4
Canagliflozin 300 mg/Phentermine 15 mg34.9

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Percent Change From Baseline in Body Weight at Week 26

The percent change from baseline in body weight at Week 26 was analysed. (NCT02243202)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
Placebo-0.6
Phentermine 15 mg-4.1
Canagliflozin 300 mg-1.9
Canagliflozin 300 mg/Phentermine 15 mg-7.5

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Change From Baseline in Systolic Blood Pressure at Week 26

Change from baseline in systolic blood pressure was analysed at week 26. (NCT02243202)
Timeframe: Week 26

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
Placebo-2.7
Phentermine 15 mg-1.4
Canagliflozin 300 mg-3.1
Canagliflozin 300 mg/Phentermine 15 mg-6.9

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Change From Baseline in Pulse Rate at Week 26

Change from baseline in pulse rate at week 26 (NCT02243202)
Timeframe: Week 26

InterventionBeats Per Minute (Beats/Min) (Least Squares Mean)
Placebo-0.7
Phentermine 15 mg4.1
Canagliflozin 300 mg0.7
Canagliflozin 300 mg/Phentermine 15 mg3.5

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Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Change from baseline in diastolic blood pressure (DBP) at week 26. (NCT02243202)
Timeframe: Week 26

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
Placebo-0.9
Phentermine 15 mg0.1
Canagliflozin 300 mg-1.5
Canagliflozin 300 mg/Phentermine 15 mg-2.5

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Absolute Change From Baseline in Body Weight at Week 26

Absolute change from baseline in body weight was analysed at week 26. (NCT02243202)
Timeframe: Week 26

InterventionKilogram (Kg) (Least Squares Mean)
Placebo-0.6
Phentermine 15 mg-4.1
Canagliflozin 300 mg-1.9
Canagliflozin 300 mg/Phentermine 15 mg-7.3

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Percent Weight Change

Percent weight loss achieved before and after surgery while taking the medication, Qsymia. (NCT02301416)
Timeframe: Pre-operatively and 24 months post-operatively

InterventionPercentage of weight change (Mean)
Phentermine/Topiramate-38.16
Surgery Only-27

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Percent Weight Change

Percent weight loss achieved before and after surgery while taking the medication, Qsymia. (NCT02301416)
Timeframe: Pre-operatively and 6 months post-operatively

InterventionPercent (Mean)
Phentermine/Topiramate-32.79
Surgery Only-27.25

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Body Mass Index

Resulting body mass index (NCT02301416)
Timeframe: 6 months post-operatively

Interventionkg/m^2 (Mean)
Phentermine/Topiramate37.61
Surgery Only41.93

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Body Mass Index

Resulting body mass index (NCT02301416)
Timeframe: 3 months post-operatively

Interventionkg/m^2 (Mean)
Phentermine/Topiramate42.31
Surgery Only45.28

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Body Mass Index

Resulting body mass index (NCT02301416)
Timeframe: 24 months post-operatively

Interventionkg/m^2 (Mean)
Phentermine/Topiramate33.79
Surgery Only41.96

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Body Mass Index

Resulting body mass index (NCT02301416)
Timeframe: 12 months post-operatively

Interventionkg/m^2 (Mean)
Phentermine/Topiramate33.46
Surgery Only39.53

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Percent Weight Change

Percent weight loss achieved before and after surgery while taking the medication, Qsymia. (NCT02301416)
Timeframe: Pre-operatively and 3 months post-operatively

InterventionPercent (Mean)
Phentermine/Topiramate-25.24
Surgery Only-21.46

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Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)

Proportion of patients who do not meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia. The criteria that suggest RYGB is indicated are: 1) BMI of 40 or greater or 2) BMI of 35-39.9 with poorly controlled co-morbidities. (NCT02301416)
Timeframe: 24 months post-operatively

InterventionParticipants (Count of Participants)
Phentermine/Topiramate8
Surgery Only19

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Percent Weight Change

Percent weight loss achieved before and after surgery while taking the medication, Qsymia. (NCT02301416)
Timeframe: Pre-operatively and 12 months post-operatively

InterventionPercent (Mean)
Phentermine/Topiramate-39.34
Surgery Only-31.43

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Corrected First Phase Insulin Secretion (IGI/HOMA-IR)

Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionindex score (Mean)
Exenatide Once Weekly (EQW )1.03
Dapagliflozin (DAPA)0.6
EQW Plus DAPA0.91
Dapagliflozin Plus Glucophage (MET ER)0.7
Phentermine /Topiramate (PHEN/ TPM) ER1.1

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Dehydroepiandrosterone Sulfate (DHEA-S) Levels

Treatment effect on blood concentrations of DHEA-S (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionmcg/dL (Mean)
Exenatide Once Weekly (EQW )165
Dapagliflozin (DAPA)187
EQW Plus DAPA169
Dapagliflozin Plus Glucophage (MET ER)189
Phentermine /Topiramate (PHEN/ TPM) ER201

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Diastolic Blood Pressure (DBP)

Treatment effect on DBP after 24 weeks (NCT02635386)
Timeframe: 24 weeks of treatment

InterventionmmHg (Mean)
Exenatide Once Weekly (EQW )81
Dapagliflozin (DAPA)79.8
EQW Plus DAPA76
Dapagliflozin Plus Glucophage (MET ER)82
Phentermine /Topiramate (PHEN/ TPM) ER83.6

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Fasting Blood Glucose

Treatment impact on fasting concentration of glucose in the blood (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionmg/dL (Mean)
Exenatide Once Weekly (EQW )91
Dapagliflozin (DAPA)93
EQW Plus DAPA86.5
Dapagliflozin Plus Glucophage (MET ER)89
Phentermine /Topiramate (PHEN/ TPM ER91.4

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Fasting Insulin Sensitivity (HOMA-IR)

Treatment effect on the ratio HOMA-IR which is insulin resistance measure derived from fasting blood glucose and insulin and is calculated by insulin (mU/ml)*glucose (mmol/L)/22,5. The higher thenumber the more insulin resistant. (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionindex score (Mean)
Exenatide Once Weekly (EQW )3.7
Dapagliflozin (DAPA)3.6
EQW Plus DAPA2.6
Dapagliflozin Plus Glucophage (MET ER)3.3
Phentermine /Topiramate (PHEN/ TPM) ER3.4

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Free Androgen Index (FAI)

Treatment effect on FAI calculated from total testosterone divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome. (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionindex score (Mean)
Exenatide Once Weekly (EQW )5.3
Dapagliflozin (DAPA)4.7
EQW Plus DAPA5.2
Dapagliflozin Plus Glucophage (MET ER)5.7
Phentermine /Topiramate (PHEN/ TPM) ER5

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Matsuda Sensitivity Index Derived From the OGTT(SI OGTT)

The SI IOGTT is a measure of peripheral insulin sensitivity derived from the values of Insulin (microunits per milliliter) and Glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values. SI (OGTT) = 10,000/ [(G fasting x I fasting) x (G OGTTmean x I OGTTmean)], where fasting glucose and insulin data are taken from time 0 of the OGTT and mean data represent the average glucose and insulin values obtained during the entire OGTT. The square root is used to correct for nonlinear distribution of insulin, and 10,000 is a scaling factor in the equation. The higher value, the more sensitive to insulin. (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionindex score (Mean)
Exenatide Once Weekly (EQW )3.1
Dapagliflozin (DAPA)3.6
EQW Plus DAPA3.9
Dapagliflozin Plus Glucophage (MET ER)4.8
Phentermine /Topiramate (PHEN/ TPM) ER4.7

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OGTT Mean Blood Glucose (MBG)

Treatment effect on MBG measured during the oral glucose tolerance test (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionmg/dL (Mean)
Exenatide Once Weekly (EQW )118
Dapagliflozin (DAPA)126.4
EQW Plus DAPA112
Dapagliflozin Plus Glucophage (MET ER)119
Phentermine /Topiramate (PHEN/ TPM ER113

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Oral Disposition (Insulin Sensitivity-insulin Secretion) Index

An estimation of β-cell compensatory function, the insulin secretion-sensitivity index (IS-SI) will be derived by applying the concept of the oral disposition index to measurements obtained during the 2-h OGTT and calculated as the index of insulin secretion factored by insulin sensitivity (ΔINS/ΔPG 30 x Matsuda SIOGTT) from the OGTT. A higher score shows improved pancreatic insulin responsiveness relative to resistance. (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionindex score (Mean)
Exenatide Once Weekly (EQW )471
Dapagliflozin (DAPA)311
EQW Plus DAPA503
Dapagliflozin Plus Glucophage (MET ER)395
Phentermine /Topiramate (PHEN/ TPM) ER545

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Systolic Blood Pressure (SBP)

Treatment effect on SBP after 24 weeks of treatment (NCT02635386)
Timeframe: 24 weeks treatment

InterventionmmHg (Mean)
Exenatide Once Weekly (EQW )123.6
Dapagliflozin (DAPA)123
EQW Plus DAPA122
Dapagliflozin Plus Glucophage (MET ER)128
Phentermine /Topiramate (PHEN/ TPM) ER124

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Total Body Fat (%) by DEXA

Treatment impact on percent total body fat by DEXA (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionpercent fat mass (Mean)
Exenatide Once Weekly (EQW )46.1
Dapagliflozin (DAPA)46.4
EQW Plus DAPA45.8
Dapagliflozin Plus Glucophage (MET ER)46.1
Phentermine /Topiramate (PHEN/ TPM) ER45.2

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Total Cholesterol Levels

Treatment effect on blood concentrations of total cholesterol (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionmg/dL (Mean)
Exenatide Once Weekly (EQW )189
Dapagliflozin (DAPA)186
EQW Plus DAPA185
Dapagliflozin Plus Glucophage (MET ER)192
Phentermine /Topiramate (PHEN/ TPM) ER178

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Total Fat Mass (kg) Evaluated by DEXA

Treatment impact on total fat mass by DEXA (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionkilogram (Mean)
Exenatide Once Weekly (EQW )47.6
Dapagliflozin (DAPA)47.8
EQW Plus DAPA45.9
Dapagliflozin Plus Glucophage (MET ER)48
Phentermine /Topiramate (PHEN/ TPM) ER44.5

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Total Testosterone Concentrations

Treatment effect on blood concentrations of total testosterone (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionng/dL (Mean)
Exenatide Once Weekly (EQW )38.8
Dapagliflozin (DAPA)35
EQW Plus DAPA42.6
Dapagliflozin Plus Glucophage (MET ER)39.5
Phentermine /Topiramate (PHEN/ TPM) ER45.5

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Triglyceride (TRG) Levels

Treatment effect on blood concentrations of triglycerides (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionmg/dL (Mean)
Exenatide Once Weekly (EQW )130
Dapagliflozin (DAPA)132
EQW Plus DAPA112
Dapagliflozin Plus Glucophage (MET ER)105
Phentermine /Topiramate (PHEN/ TPM) ER110

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Trunk/Leg Fat Ratio by DEXA

Treatment impact on trunk/limb ratio (measure of central adiposity) by DEXA (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionratio (Mean)
Exenatide Once Weekly (EQW )1.03
Dapagliflozin (DAPA).95
EQW Plus DAPA.93
Dapagliflozin Plus Glucophage (MET ER).98
Phentermine /Topiramate (PHEN/ TPM) ER.99

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Waist-to-Hip Ratio (WHR)

Treatment impact on central adiposity after 24 weeks (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionratio (Mean)
Exenatide Once Weekly (EQW ).83
Dapagliflozin (DAPA).79
EQW Plus DAPA.86
Dapagliflozin Plus Glucophage (MET ER).83
Phentermine /Topiramate (PHEN/ TPM) ER.81

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Body Mass Index (BMI)

Treatment efficacy in reducing body mass at 24 weeks of treatment (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionkilogram/meter squared (Mean)
Exenatide Once Weekly (EQW )37.3
Dapagliflozin (DAPA)37.4
EQW Plus DAPA36.7
Dapagliflozin Plus Glucophage (MET ER)37
Phentermine /Topiramate (PHEN/ TPM) ER35.3

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Absolute Body Weight

Treatment effect on body weight at 24 weeks of treatment (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionkilogram (Mean)
Exenatide Once Weekly (EQW )100.4
Dapagliflozin (DAPA)102.6
EQW Plus DAPA99
Dapagliflozin Plus Glucophage (MET ER)101.2
Phentermine /Topiramate (PHEN/ TPM) ER97

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Android-Gynoid Ratio (AGR) as Determined by DEXA

treatment impact on measure of central adiposity as determined by android/gynoid ratio (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionratio (Mean)
Exenatide Once Weekly (EQW )1.07
Dapagliflozin (DAPA)1.02
EQW Plus DAPA1.04
Dapagliflozin Plus Glucophage (MET ER)1.04
Phentermine /Topiramate (PHEN/ TPM) ER1.03

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Waist-to-Height Ratio (WHtR)

Treatment impact on WHtR which is a measure of central adiposity (NCT02635386)
Timeframe: 24 weeks of treatment

Interventionratio (Mean)
Exenatide Once Weekly (EQW ).64
Dapagliflozin (DAPA).61
EQW Plus DAPA.65
Dapagliflozin Plus Glucophage (MET ER).61
Phentermine /Topiramate (PHEN/ TPM) ER.59

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Central Adiposity (Waist Circumference)

Treatment effect on loss of central adiposity after 24 weeks (NCT02635386)
Timeframe: 24 weeks of treatment

Interventioncentimeters (Mean)
Exenatide Once Weekly (EQW )104
Dapagliflozin (DAPA)101
EQW Plus DAPA106
Dapagliflozin Plus Glucophage (MET ER)101.3
Phentermine /Topiramate (PHEN/ TPM) ER97

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Change in Percent Body Weight

Treatment effect on change in percent body weight from baseline (NCT02635386)
Timeframe: Change from baseline (time 0) to study end (24 weeks)

Interventionpercentage change in body weight (Mean)
Exenatide Once Weekly (EQW )3.8
Dapagliflozin (DAPA)1.5
EQW Plus DAPA6.9
Dapagliflozin Plus Glucophage (MET ER)1.7
Phentermine /Topiramate (PHEN/ TPM) ER8.1

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Change in HOMA-IR

Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56 (NCT02714062)
Timeframe: 56 days

InterventionμIU/mL (Mean)
Placebo0.65
VI-0521 Mid Dose-2.46
VI-0521 Top Dose-1.82

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Change in Visual Analog Scale (VAS) Hunger Scores

"Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors not at all hungry and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors extremely hungry all the time and corresponds to a VAS hunger score of 10.0. Subjects were asked Please mark with a perpendicular line on the scale how hungry you were overall during the past week: to best describes their overall level of hunger during the past week. Research staff measure the distance between the 0.0 = not at all hungry anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure." (NCT02714062)
Timeframe: 56 days

Interventionunits on a scale (Mean)
Placebo-0.48
VI-0521 Mid Dose-1.26
VI-0521 Top Dose-3.28

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Change in Visual Analog Scale (VAS) Satiety Scores

"Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors very satisfied and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors not all at satisfied and corresponds to a VAS satiety score of 10.0. Subjects were asked Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week: to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the 0.0 = very satisfied anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure." (NCT02714062)
Timeframe: 56 days

Interventionunits on a scale (Mean)
Placebo-0.74
VI-0521 Mid Dose-0.65
VI-0521 Top Dose0.18

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Change in Waist Circumference

Mean change in waist circumference from baseline to Day 56 (NCT02714062)
Timeframe: 56 days

Interventioncm (Mean)
Placebo0.1
VI-0521 Mid Dose-2.6
VI-0521 Top Dose-4.8

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Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)

Mean changes in glycemic parameters [Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT [glucose concentration (mg/dL) (fasting)*insulin concentration (uIU/mL) (fasting)*glucose concentration (mg/dL) (2 hours after glucose load)*insulin concentration (uIU/ mL) (2 hours after glucose load)], with higher numbers indicating better insulin sensitivity. (NCT02714062)
Timeframe: 56 days

InterventionIndex (Mean)
Placebo-0.19
VI-0521 Mid Dose0.55
VI-0521 Top Dose2.13

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Weight Loss

Mean percent weight change from baseline to Day 56 (NCT02714062)
Timeframe: 56 days

InterventionPercent weight change (Mean)
Placebo1.14
VI-0521 Mid Dose-3.77
VI-0521 Top Dose-4.99

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Apparent Clearance (CL/F) of Phentermine and Topiramate

A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters. (NCT02714062)
Timeframe: On Days 14, 28, 42, and 56

,
InterventionL/h (Mean)
Day 14 (Phentermine)Day 28 (Phentermine)Day 42 (Phentermine)Day 56 (Phentermine)Day 14 (Topiramate)Day 28 (Topiramate)Day 42 (Topiramate)Day 56 (Topiramate)
VI-0521 Mid Dose7.337.336.826.821.321.321.251.25
VI-0521 Top Dose7.047.186.496.671.251.271.201.18

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Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate

A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. (NCT02714062)
Timeframe: On Days 14, 28, 42, and 56

,
InterventionL (Mean)
Day 14 (Phentermine)Day 28 (Phentermine)Day 42 (Phentermine)Day 56 (Phentermine)Day 14 (Topiramate)Day 28 (Topiramate)Day 42 (Topiramate)Day 56 (Topiramate)
VI-0521 Mid Dose28928728428146.846.245.745.2
VI-0521 Top Dose28929129829946.146.648.247.5

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Area Under the Curve (AUC) of Phentermine

A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state. (NCT02714062)
Timeframe: On Days 14, 28, 42, and 56

,
Interventionng•h/mL (Mean)
Day 14 (Phentermine)Day 28 (Phentermine)Day 42 (Phentermine)Day 56 (Phentermine)
VI-0521 Mid Dose533106611541154
VI-0521 Top Dose600117119022469

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Area Under the Curve (AUC) of Topiramate

A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state. (NCT02714062)
Timeframe: On Days 14, 28, 42, and 56

,
Interventionμg•h/mL (Mean)
Day 14 (Topiramate)Day 28 (Topiramate)Day 42 (Topiramate)Day 56 (Topiramate)
VI-0521 Mid Dose18.537.038.838.8
VI-0521 Top Dose19.438.260.181.4

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Change in Blood Pressure

Mean change in blood pressure from baseline to Day 56 (NCT02714062)
Timeframe: 56 days

,,
InterventionmmHg (Mean)
Mean change in systolic BPMean change in diastolic BP
Placebo-6.0-2.2
VI-0521 Mid Dose-3.33.5
VI-0521 Top Dose-3.82.1

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Change in Lipid Parameters

Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56 (NCT02714062)
Timeframe: 56 days

,,
InterventionPercent Change (Mean)
Mean Percent Change in TCMean Percent Change in LDL-CMean Percent Change in HDL-CMean Percent Change in TG
Placebo0.262.89-3.167.54
VI-0521 Mid Dose-6.10-4.42-6.620.05
VI-0521 Top Dose-1.738.99-12.55-8.05

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Change in OGTT of Fasting and 2-hour Glucose

Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56 (NCT02714062)
Timeframe: 56 days

,,
Interventionmg/dL (Mean)
Mean Change in OGTT of Fasting Serum GlucoseMean Change in OGTT of 2-Hour Serum GlucoseMean Change in OGTT of Fasting Serum InsulinMean Change in OGTT of 2-Hour Serum Insulin
Placebo-3.2-1.23.2811.45
VI-0521 Mid Dose0.6-3.9-10.92-54.13
VI-0521 Top Dose-2.1-9.3-8.03-92.99

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Maximum Concentration (Cmax) of Phentermine

A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. (NCT02714062)
Timeframe: On Days 14, 28, 42, and 56

,
Interventionng/mL (Mean)
Day 14 (Phentermine)Day 28 (Phentermine)Day 42 (Phentermine)Day 56 (Phentermine)
VI-0521 Mid Dose27.655.359.059.1
VI-0521 Top Dose30.359.394.2123

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Maximum Concentration (Cmax) of Topiramate

A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. (NCT02714062)
Timeframe: On Days 14, 28, 42, and 56

,
Interventionμg/mL (Mean)
Day 14 (Topiramate)Day 28 (Topiramate)Day 42 (Topiramate)Day 56 (Topiramate)
VI-0521 Mid Dose0.9171.841.921.92
VI-0521 Top Dose0.9521.882.903.93

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Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary

"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health." (NCT02911818)
Timeframe: Randomization and 52 weeks

InterventionT scores (Mean)
CMS-Alone4.4
CMS-Liraglutide2.1
Multi-Component Intervention3.4

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Change 36-Item Short Form Survey (SF-36) - Mental Component Summary

"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health." (NCT02911818)
Timeframe: Randomization and 52 weeks

InterventionT scores (Mean)
CMS-Alone0.8
CMS-Liraglutide4.5
Multi-Component Intervention6.4

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Extension Study Secondary Outcome: Change in c-Reactive Protein

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmg/L (Mean)
12-Week Extension Study: Placebo Group-0.8
12-Week Extension Study: Phentermine Group-0.6

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Percent Change in Baseline Weight

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionpercent change (Mean)
CMS-Alone-6.1
CMS-Liraglutide-11.5
Multi-Component Intervention-11.8

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Extension Study Secondary Outcome: SF-36 - Physical Health Component

"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health." (NCT02911818)
Timeframe: Re-randomization and 12 weeks

InterventionT scores (Mean)
12-Week Extension Study: Placebo Group0.3
12-Week Extension Study: Phentermine Group-1.2

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Extension Study Secondary Outcome: SF-36 - Mental Health Component

"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health." (NCT02911818)
Timeframe: Re-randomization and 12 weeks

InterventionT scores (Mean)
12-Week Extension Study: Placebo Group-0.1
12-Week Extension Study: Phentermine Group0.2

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Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)

PHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score. (NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionscore on a scale (Mean)
12-Week Extension Study: Placebo Group0.2
12-Week Extension Study: Phentermine Group0.0

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Extension Study Secondary Outcome: Change in Waist Circumference

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventioncm (Mean)
12-Week Extension Study: Placebo Group-0.6
12-Week Extension Study: Phentermine Group-0.4

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Extension Study Secondary Outcome: Change in Triglycerides

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmg/dL (Mean)
12-Week Extension Study: Placebo Group4.1
12-Week Extension Study: Phentermine Group6.6

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Extension Study Secondary Outcome: Change in Total Cholesterol

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmg/dL (Mean)
12-Week Extension Study: Placebo Group3.4
12-Week Extension Study: Phentermine Group0.4

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Extension Study Secondary Outcome: Change in Systolic Blood Pressure

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmm Hg (Mean)
12-Week Extension Study: Placebo Group1.2
12-Week Extension Study: Phentermine Group2.0

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Extension Study Secondary Outcome: Change in LDL Cholesterol

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmg/dL (Mean)
12-Week Extension Study: Placebo Group2.3
12-Week Extension Study: Phentermine Group-2.4

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Extension Study Secondary Outcome: Change in HOMA-IR

HOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement (NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmg/dL*µIU/mL/405 (Mean)
12-Week Extension Study: Placebo Group0.1
12-Week Extension Study: Phentermine Group0.3

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Extension Study Secondary Outcome: Change in Heart Rate

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

InterventionBeats per minute (Mean)
12-Week Extension Study: Placebo Group0
12-Week Extension Study: Phentermine Group2.1

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Extension Study Secondary Outcome: Change in HDL Cholesterol

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmg/dL (Mean)
12-Week Extension Study: Placebo Group0.6
12-Week Extension Study: Phentermine Group2.0

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Extension Study Secondary Outcome: Change in HbA1c

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionpercentage (Mean)
12-Week Extension Study: Placebo Group0.0
12-Week Extension Study: Phentermine Group0.0

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Extension Study Secondary Outcome: Change in Fasting Insulin

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

InterventionuIU/mL (Mean)
12-Week Extension Study: Placebo Group0.2
12-Week Extension Study: Phentermine Group0.5

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Extension Study Secondary Outcome: Change in Fasting Glucose

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmg/dL (Mean)
12-Week Extension Study: Placebo Group1.4
12-Week Extension Study: Phentermine Group6.3

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Extension Study Secondary Outcome: Change in Diastolic Blood Pressure

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionmm Hg (Mean)
12-Week Extension Study: Phentermine Group1.3
12-Week Extension Study: Placebo Group0.2

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Extension Study Primary Outcome: Percent Change in Re-randomization Weight

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Interventionpercent change (Mean)
12-Week Extension Study: Phentermine Group-1.6
12-Week Extension Study: Placebo Group-0.1

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Change in Waist Circumference

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventioncm (Mean)
CMS-Alone-6.5
CMS-Liraglutide-11.1
Multi-Component Intervention-12.6

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Change in Triglycerides

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmg/dL (Mean)
CMS-Alone-16.3
CMS-Liraglutide-21.3
Multi-Component Intervention-14.4

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Change in Total Cholesterol

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmg/dL (Mean)
CMS-Alone-7.0
CMS-Liraglutide-9.7
Multi-Component Intervention-10.0

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Change in Fasting Insulin

(NCT02911818)
Timeframe: Randomization and 52 weeks

InterventionuIU/mL (Mean)
CMS-Alone-1.5
CMS-Liraglutide-1.1
Multi-Component Intervention-1.5

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Change in Systolic Blood Pressure

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmm Hg (Mean)
CMS-Alone-14.1
CMS-Liraglutide-13.3
Multi-Component Intervention-15.3

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Change in Patient Health Questionnaire (PHQ-9)

PHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score. (NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionscore on a scale (Mean)
CMS-Alone-1.8
CMS-Liraglutide-1.9
Multi-Component Intervention-1.5

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Change in LDL Cholesterol

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmg/dL (Mean)
CMS-Alone-3.3
CMS-Liraglutide-9.6
Multi-Component Intervention-9.4

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Change in HOMA-IR

HOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement (NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmg/dL*µIU/mL/405 (Mean)
CMS-Alone-0.4
CMS-Liraglutide-0.3
Multi-Component Intervention-0.4

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Change in Heart Rate

(NCT02911818)
Timeframe: Randomization and 52 weeks

InterventionBeats per minute (Mean)
CMS-Alone-7.4
CMS-Liraglutide-5.3
Multi-Component Intervention9.7

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Change in HDL Cholesterol

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmg/dL (Mean)
CMS-Alone-1.3
CMS-Liraglutide3.0
Multi-Component Intervention2.0

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Change in HbA1c

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionpercentage (Mean)
CMS-Alone-0.3
CMS-Liraglutide-0.5
Multi-Component Intervention-0.6

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Change in Fasting Glucose

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmg/dL (Mean)
CMS-Alone0.01
CMS-Liraglutide-5.2
Multi-Component Intervention-5.7

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Change in Diastolic Blood Pressure

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmm Hg (Mean)
CMS-Alone-3.0
CMS-Liraglutide-2.9
Multi-Component Intervention-3.5

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Change in C Reactive Protein

(NCT02911818)
Timeframe: Randomization and 52 weeks

Interventionmg/L (Mean)
CMS-Alone-0.4
CMS-Liraglutide-2.0
Multi-Component Intervention-3.0

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Percentage of Responders

Percentage of participants who loss 5% or more of total body weight (NCT03374956)
Timeframe: baseline to 12 weeks

Interventionpercentage of participants (Number)
Intervention Group81
Control Group80

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Percentage of Responders

Percentage of participants with at least 10% total body weight loss (NCT03374956)
Timeframe: baseline to 12 weeks

Interventionpercentage of participants (Number)
Intervention Group44
Control Group40

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Change in Total Body Weight

Percent change in body weight (NCT03374956)
Timeframe: baseline to 12 weeks

Interventionpercent change (Median)
Intervention Group-7.7
Control Group-6.5

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Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56

(NCT03922945)
Timeframe: Baseline to Week 56

Interventionpercentage of participants (Number)
Placebo2.9
VI-0521 Mid Dose13.6
VI-0521 Top Dose28.9

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Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56

(NCT03922945)
Timeframe: Baseline to Week 56

Interventionpercentage of participants (Number)
Placebo4.5
VI-0521 Mid Dose33.5
VI-0521 Top Dose44.4

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Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56

(NCT03922945)
Timeframe: Baseline to Week 56

Interventionpercentage of participants (Number)
Placebo13.6
VI-0521 Mid Dose44
VI-0521 Top Dose52.2

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Percent Change in HDL-C From Baseline to Week 56

(NCT03922945)
Timeframe: Baseline, Week 56

InterventionPercent Change (Least Squares Mean)
Placebo-4.3
VI-0521 Mid Dose2.11
VI-0521 Top Dose0.65

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Mean % Change in Body Mass Index (BMI)

Mean % change in BMI from Baseline to Week 56 (NCT03922945)
Timeframe: Baseline to Week 56

InterventionPercentage Change (Least Squares Mean)
Placebo3.34
VI-0521 Mid Dose-4.78
VI-0521 Top Dose-7.11

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Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56

Mean changes in glycemic parameters [Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)] from baseline to Week 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Week 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT [glucose concentration (mg/dL) (fasting)*insulin concentration (uIU/mL) (fasting)*glucose concentration (mg/dL) (2 hours after glucose load)*insulin concentration (uIU/mL) (2 hours after glucose load)], with higher numbers indicating better insulin sensitivity. (NCT03922945)
Timeframe: Baseline, Week 56

InterventionIndex (Least Squares Mean)
Placebo-3.7
VI-0521 Mid Dose-3.93
VI-0521 Top Dose-2.99

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Change in Waist Circumference at Week 56

Change in waist circumference from Baseline to Week 56 (NCT03922945)
Timeframe: Baseline, Week 56

InterventionCentimeter (Least Squares Mean)
Placebo0.61
VI-0521 Mid Dose-5.03
VI-0521 Top Dose-6.98

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Change in Fasting Insulin at Week 56

Change in fasting insulin from Baseline to Week 56 (NCT03922945)
Timeframe: Baseline, Week 56

InterventionuIU/mL (Least Squares Mean)
Placebo-3.32
VI-0521 Mid Dose-11.47
VI-0521 Top Dose-7.99

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Change From Baseline in Systolic Blood Pressure at Week 56

(NCT03922945)
Timeframe: Baseline, Week 56

InterventionmmHg (Least Squares Mean)
Placebo2.86
VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)0.09
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)1.84

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Change From Baseline in Diastolic Blood Pressure at Week 56

(NCT03922945)
Timeframe: Baseline, Week 56

InterventionmmHg (Least Squares Mean)
Placebo3.41
VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)0.24
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)1.22

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Percent Change in Triglycerides From Baseline to Week 56

(NCT03922945)
Timeframe: Baseline, Week 56

InterventionPercent Change (Least Squares Mean)
Placebo5.56
VI-0521 Mid Dose-6.18
VI-0521 Top Dose-5.59

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Body Weight Change

Change in weight calculated in kilograms. (NCT04408586)
Timeframe: baseline, 12 months

Interventionkilograms (Mean)
Phentermine - Topiramate Extended Release Group-15.32
Placebo Group-5.85

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Body Weight Change

Change in weight calculated in kilograms. (NCT04408586)
Timeframe: baseline, 3 months

Interventionkilograms (Mean)
Phentermine - Topiramate Extended Release Group-10.80
Placebo Group-4.04

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Tracker Usage

The amount of time in minutes the tracker was used per week (NCT04408586)
Timeframe: 12 months

Interventionminutes/week (Mean)
Phentermine - Topiramate Extended Release Group90
Placebo Group94

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Exercise Sessions

The number of exercise sessions per week (NCT04408586)
Timeframe: 12 months

Interventionsessions per week (Mean)
Phentermine - Topiramate Extended Release Group2.3
Placebo Group2.1

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Change in Step Count

The change in the number of steps per day (NCT04408586)
Timeframe: baseline,12 months

Interventionsteps per day (Mean)
Phentermine - Topiramate Extended Release Group1214
Placebo Group2316

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Change in Calories

The change in calories burned per day (NCT04408586)
Timeframe: baseline, 12 months

Interventionkcal per day (Mean)
Phentermine - Topiramate Extended Release Group-193
Placebo Group60

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Percentage of Patients Who Achieved More Than 5% Weight Loss Over the Course of the Study (12 Weeks)

(NCT04614545)
Timeframe: 12 weeks

InterventionPercentage of patients with >5% wt loss (Number)
Virtual Visits64.7
Face to Face Visits70.5

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Change in Body Weight (Percentage)

The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight. (NCT04614545)
Timeframe: 12 weeks

Interventionmean change in body weight (%) (Mean)
Virtual Visits-6.61
Face to Face Visits-7.68

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Adherence to Weight Management Program

Assessed as percentage of patients who completed all visits (NCT04614545)
Timeframe: 12 weeks

InterventionPercentage of completed patients (Number)
Virtual Visits82.9
Face to Face Visits62.9

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Adherence to Medication Use

Percentage of patients that took the medication as prescribed (NCT04614545)
Timeframe: 12 weeks

InterventionPercentage of pts completed medication (Number)
Virtual Visits93.3
Face to Face Visits83.3

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Percentage of Patients That Tolerated Full Dosage of Phentermine (37.5mg)

(NCT04614545)
Timeframe: 12 weeks

InterventionPercentage of patients on full dose (Number)
Virtual Visits85.7
Face to Face Visits90

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