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

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.

Inclusion Criteria:

• Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
• BMI ≥25 kg/m2
• Type 2 diabetes mellitus is allowed
• Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
• Stable body weight during the past 3 months, except for during home visits

Exclusion Criteria:

• Use of weight loss agents in the past 3 months
• Type 1 diabetes mellitus
• Current or anticipated chronic use of narcotics or opiates