NCT02179151

Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome

Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Zafgen, Inc. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.

Detailed description

Phase 3, Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects with Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months

Conditions

• Prader-Willi Syndrome
• Obesity

Interventions

Type	Name	Description
DRUG	ZGN-440 for Injectable Suspension	Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
DRUG	ZGN-440 Placebo for Injectable Suspension	Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-12-01
• Completion: 2016-10-01
• First posted: 2014-07-01
• Last updated: 2017-01-26

Locations

15 sites across 1 country: United States