Overview

This trial is active, not recruiting.

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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
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

Male or female 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 2016.
Information provided to ClinicalTrials.gov by Zafgen, Inc..