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TerminatedNCT02179151bestPWSUpdated Jan 26, 2017

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

A Phase 3 interventional study of ZGN-440 for Injectable Suspension and ZGN-440 Placebo for Injectable Suspension in Prader-Willi Syndrome and Obesity, sponsored by Zafgen, Inc.. Terminated at 15 sites in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Zafgen, Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated
FDA Clinical Hold
Phase
Phase 3
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
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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.

Read the 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

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Conditions studied

  • Prader-Willi Syndrome
  • Obesity

Keywords

  • Prader-Willi Syndrome
  • Obesity
  • Hyperphagia
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In context

Prader-Willi Syndrome

138 studies on the registry are indexed under Prader-Willi Syndrome; 24 are open to participants now.

This study's enrollment of 108 is above the median of 30 across 96 interventional studies indexed under Prader-Willi Syndrome.

Browse Prader-Willi Syndrome studies →

Lead sponsor

Zafgen, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Intervention: ZGN-440 Placebo for Injectable Suspension

    Drug: ZGN-440 Placebo for Injectable Suspension

  • Experimental
    ZGN-440 Injectable Suspension (1.8 mg)

    Intervention: ZGN-440 for Injectable Suspension

    Drug: ZGN-440 for Injectable Suspension

  • Experimental
    ZGN-440 Injectable Suspension (2.4 mg)

    Intervention: ZGN-440 for Injectable Suspension

    Drug: ZGN-440 for Injectable Suspension

Interventions

  • DrugZGN-440 for Injectable Suspension

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

    Also known as: ZGN-440, Beloranib

  • DrugZGN-440 Placebo for Injectable Suspension

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

    Also known as: Placebo

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What researchers measure

Primary outcomes

  1. Change in total body weight

    Time frame: Baseline to Week 29

  2. Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire

    Time frame: Baseline to Week 29

Secondary outcomes

  1. Change in LDL cholesterol

    Time frame: Baseline to Week 29

  2. Change in HDL cholesterol

    Time frame: Baseline to Week 29

  3. Change in total body mass as measured by DXA

    Time frame: Baseline to Week 29

  4. Change in total body fat mass as measured by DXA

    Time frame: Baseline to Week 29

  5. Change in triglyceride

    Time frame: Baseline to Week 29

07

Study locations

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

Publications

  • McCandless SE, Yanovski JA, Miller J, Fu C, Bird LM, Salehi P, Chan CL, Stafford D, Abuzzahab MJ, Viskochil D, Barlow SE, Angulo M, Myers SE, Whitman BY, Styne D, Roof E, Dykens EM, Scheimann AO, Malloy J, Zhuang D, Taylor K, Hughes TE, Kim DD, Butler MG. Effects of MetAP2 inhibition on hyperphagia and body weight in Prader-Willi syndrome: A randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Dec;19(12):1751-1761. doi: 10.1111/dom.13021. Epub 2017 Jul 13. PubMed 28556449 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02179151
Lead sponsor
Zafgen, Inc.
Responsible party
Sponsor
First posted
Jul 1, 2014
Start date
Sep 2014
Primary completion
Dec 2015
Completion
Oct 2016
Last update
Jan 26, 2017

Study contacts

Dennis Kim, MD
study director · Zafgen, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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