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

• Status: Terminated
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zafgen, Inc.
• Treatments: CKD732

Criteria

Inclusion Criteria:

• Confirmed genetic diagnosis of Prader-Willi Syndrome

• Age 12-65

• Obesity

• Age 12-17: BMI ≥ 95th percentile for age and gender

• Age 18-65: BMI ≥27 to ≤60 kg/m2

Exclusion Criteria:

• Subjects living in a group home ≥ 50% of the time

• Recent use (within 3 months) of weight loss agents including herbal medication

• Poorly controlled severe psychiatric disorders