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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity, Over-weight, Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT01818921

Run by

Zafgen, Inc.

People needed

17

Starts

2013-06-01

Expected to finish

2013-11-01

Last updated by the study team

2016-07-18

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.