An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 10/3/2013 |
| Start Date: | June 2013 |
| End Date: | December 2013 |
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
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