Overview

This trial has been terminated.

Conditions prader-willi syndrome, obesity
Treatments zgn-440 for injectable suspension, zgn-440 placebo for injectable suspension
Phase phase 3
Sponsor Zafgen, Inc.
Start date September 2014
End date December 2015
Trial size 108 participants
Trial identifier NCT02179151, ZAF-311

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator, outcomes assessor
Arm
(Placebo Comparator)
Intervention: ZGN-440 Placebo for Injectable Suspension
zgn-440 placebo for injectable suspension Placebo
Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.
(Experimental)
Intervention: ZGN-440 for Injectable Suspension
zgn-440 for injectable suspension ZGN-440
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
(Experimental)
Intervention: ZGN-440 for Injectable Suspension
zgn-440 for injectable suspension ZGN-440
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.

Primary Outcomes

Measure
Change in total body weight
time frame: Baseline to Week 29
Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire
time frame: Baseline to Week 29

Secondary Outcomes

Measure
Change in LDL cholesterol
time frame: Baseline to Week 29
Change in HDL cholesterol
time frame: Baseline to Week 29
Change in total body mass as measured by DXA
time frame: Baseline to Week 29
Change in total body fat mass as measured by DXA
time frame: Baseline to Week 29
Change in triglyceride
time frame: Baseline to Week 29

Eligibility Criteria

All participants from 12 years up to 65 years old.

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

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Zafgen, Inc..