An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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