An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

NCT02063295 ↗

Phase 2 Completed 14 enrolled Zafgen, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.

Timeline

Start: 2014-04
Primary completion: 2014-11
Completion: 2014-11

Outcome

Met primary endpoint

paper Compared with placebo (N = 4), beloranib 1.8 mg (N = 8) resulted in a mean (95% CI) difference in weight of -3.2 (-5.4, -0.9) kg after 4 weeks. PMID 28261955 ↗

Publications

Shoemaker A, Proietto J, Abuzzahab MJ, Markovic T, Malloy J, Kim DD. A randomized, placebo-controlled trial of beloranib for the treatment of hypothalamic injury-associated obesity. Diabetes Obes Metab. 2017 Aug;19(8):1165-1170. doi: 10.1111/dom.12928. Epub 2017 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Beloranib	Small molecule	1.8 mg	Subcutaneous