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

January 24, 2017 updated by: Zafgen, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • San Diego, California, United States, 92123
        • UCSD: Rady Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital of Colorado
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Child Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • Children's Hospital and Clinics of Minnesota
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Saint Louis University
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Intervention: ZGN-440 Placebo for Injectable Suspension
Drug: ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.
Other Names:
  • Placebo
Experimental: ZGN-440 Injectable Suspension (1.8 mg)
Intervention: ZGN-440 for Injectable Suspension
Drug: ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
Other Names:
  • ZGN-440
  • Beloranib
Experimental: ZGN-440 Injectable Suspension (2.4 mg)
Intervention: ZGN-440 for Injectable Suspension
Drug: ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
Other Names:
  • ZGN-440
  • Beloranib

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zafgen, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 29, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZAF-311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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