Status:
COMPLETED
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
Lead Sponsor:
Zafgen, Inc.
Conditions:
Obesity
Over-weight
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Use of weight loss agents in the past 3 months
- Type 1 diabetes mellitus
- Current or anticipated chronic use of narcotics or opiates
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01818921
Start Date
June 1 2013
End Date
November 1 2013
Last Update
July 18 2016
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610-0296