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



Status:Terminated
Conditions:Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:12 - 65
Updated:12/16/2016
Start Date:September 2014
End Date:October 2016

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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
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