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

NCT02179151 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-01-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ZGN-440 for Injectable Suspension

Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.

DRUG

ZGN-440 Placebo for Injectable Suspension

Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.

Sponsors & Collaborators

  • Zafgen, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Kim, MD · Zafgen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02179151 on ClinicalTrials.gov