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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02179151
Other study ID # ZAF-311
Secondary ID
Status Terminated
Phase Phase 3
First received June 25, 2014
Last updated January 24, 2017
Start date September 2014
Est. completion date October 2016

Study information

Verified date January 2017
Source Zafgen, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 108
Est. completion date October 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 12 Years to 65 Years
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Zafgen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in total body weight Baseline to Week 29
Primary Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire Baseline to Week 29
Secondary Change in LDL cholesterol Baseline to Week 29
Secondary Change in HDL cholesterol Baseline to Week 29
Secondary Change in total body mass as measured by DXA Baseline to Week 29
Secondary Change in total body fat mass as measured by DXA Baseline to Week 29
Secondary Change in triglyceride Baseline to Week 29
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