ckd732 and Cardiovascular-Diseases

Hypothalamic injury-associated obesity (HIAO) results from damage to the hypothalamus that often occurs with surgical removal/radiation therapy of tumours in the hypothalamic region, such as craniopharyngioma. There is currently no rigorously studied pharmaceutical treatment for the intractable weight gain and cardiometabolic consequences that occur in patients with HIAO. We aimed to assess efficacy, safety and tolerability of beloranib treatment for 4 to 8 weeks in patients with HIAO.. This Phase 2a, double-blind, placebo-controlled study included 14 patients with HIAO, randomized to receive beloranib 1.8 mg or placebo subcutaneously twice weekly for 4 weeks with an optional 4-week open-label extension in which all patients received beloranib. The primary endpoint was change in weight from baseline to Week 4.. Participants were 64% female, with a mean (SD) age of 32 (9) years, BMI of 43 (7) kg/m. Beloranib treatment resulted in progressive weight loss in patients with HIAO that was comparable to that observed with beloranib in patients with exogenous obesity. These findings indicate a novel mechanism for treating obesity in patients with HIAO.

Topics: Adult; Aminopeptidases; Appetite Depressants; Biomarkers; Body Mass Index; Cardiovascular Diseases; Cinnamates; Cohort Studies; Cyclohexanes; Double-Blind Method; Enzyme Inhibitors; Epoxy Compounds; Female; Follow-Up Studies; Glycoproteins; Humans; Hypothalamus; Injections, Subcutaneous; Male; Metabolic Syndrome; Methionyl Aminopeptidases; Obesity, Morbid; Proof of Concept Study; Risk; Sesquiterpenes; Weight Loss; Young Adult