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

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 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

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