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

Phase 3

Terminated

• Conditions: Prader-Willi Syndrome; Obesity
• Interventions: Drug: ZGN-440 Placebo for Injectable Suspension; Drug: ZGN-440 for Injectable Suspension

• Registration Number: NCT02179151
• Lead Sponsor: Zafgen, Inc.

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-29
• Study First Posted: 2014-07-01
• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2016-10
• Status Verified: 2017-01
• Disposition First Submitted: 2017-01-24
• Disposition First Submitted QC: 2017-01-24
• Last Update Submitted: 2017-01-24
• Disposition First Posted: 2017-01-26
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	ZGN-440 Placebo for Injectable Suspension	Intervention: ZGN-440 Placebo for Injectable Suspension
ZGN-440 Injectable Suspension (1.8 mg)	ZGN-440 for Injectable Suspension	Intervention: ZGN-440 for Injectable Suspension
ZGN-440 Injectable Suspension (2.4 mg)	ZGN-440 for Injectable Suspension	Intervention: ZGN-440 for Injectable Suspension

Primary Outcome Measures

Name	Time	Method
Change in total body weight	Baseline to Week 29
Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire	Baseline to Week 29

Secondary Outcome Measures

Name	Time	Method
Change in LDL cholesterol	Baseline to Week 29
Change in total body fat mass as measured by DXA	Baseline to Week 29
Change in HDL cholesterol	Baseline to Week 29
Change in total body mass as measured by DXA	Baseline to Week 29
Change in triglyceride	Baseline to Week 29

Trial Locations

Locations (15)

Winthrop University; 🇺🇸 Mineola, New York, United States

UCSD: Rady Children's Hospital; 🇺🇸 San Diego, California, 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

Children's Hospital and Clinics of Minnesota; 🇺🇸 St. Paul, Minnesota, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Children's Hospital of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

National Institute of Child Health; 🇺🇸 Bethesda, Maryland, United States

Saint Louis University; 🇺🇸 St. Louis, Missouri, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States