NCT01818921

An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome

Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Zafgen, Inc. · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.

Conditions

• Obesity
• Over-weight
• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	ZGN-440 sterile diluent	ZGN-440 sterile diluent/placebo
DRUG	1.2 mg ZGN-440 for injectable suspension	1.2 mg beloranib
DRUG	1.8 mg ZGN-440 for injectable suspension	1.8 mg beloranib

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-03-27
• Last updated: 2016-07-18

Locations

1 site across 1 country: United States