Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Prader-Willi Syndrome, Obesity

In brief

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.

Key facts

Study ID

NCT02179151

Run by

Zafgen, Inc.

People needed

108

Starts

2014-09-01

Expected to finish

2016-10-01

Last updated by the study team

2017-01-26

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed genetic diagnosis of Prader-Willi Syndrome
• Age 12-65
• Obesity
• Age 12-17: BMI ≥ 95th percentile for age and gender
• Age 18-65: BMI ≥27 to ≤60 kg/m2

You may not qualify if…

• Subjects living in a group home ≥ 50% of the time
• Recent use (within 3 months) of weight loss agents including herbal medication
• Poorly controlled severe psychiatric disorders

Where it is running

• University of California, Davis — Sacramento, California, United States
• UCSD: Rady Children's Hospital — San Diego, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• National Institute of Child Health — Bethesda, Maryland, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Children's Hospital and Clinics of Minnesota — Saint Paul, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Winthrop University — Mineola, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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