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

Last updated: January 24, 2017
Sponsor: Zafgen, Inc.
Overall Status: Terminated

Phase

3

Condition

Severe Short Stature

Hypogonadism

Obesity

Treatment

N/A

Clinical Study ID

NCT02179151
ZAF-311
  • Ages 12-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 108
Study Start date:
September 01, 2014
Estimated Completion Date:
October 31, 2016

Study Description

Phase 3, Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects with Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months

Connect with a study center

  • University of California, Davis

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSD: Rady Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Children's Hospital of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • National Institute of Child Health

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • Children's Hospital Boston

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Children's Hospital and Clinics of Minnesota

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • Saint Louis University

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Winthrop University

    Mineola, New York 11501
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37235
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Seattle Children's Research Institute

    Seattle, Washington 98105
    United States

    Site Not Available

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