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

Obesity Clinical Trial

— bestPWS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02179151
• Other study ID #: ZAF-311
• 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
• 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

Related Conditions & MeSH terms

• Obesity
• Prader-Willi Syndrome
• Syndrome

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