Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
NCT ID: NCT02179151
Last Updated: 2017-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
108 participants
INTERVENTIONAL
2014-09-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Intervention: ZGN-440 Placebo for Injectable Suspension
ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.
ZGN-440 Injectable Suspension (1.8 mg)
Intervention: ZGN-440 for Injectable Suspension
ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
ZGN-440 Injectable Suspension (2.4 mg)
Intervention: ZGN-440 for Injectable Suspension
ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
Interventions
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ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Recent use (within 3 months) of weight loss agents including herbal medication
* Poorly controlled severe psychiatric disorders
12 Years
65 Years
ALL
No
Sponsors
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Zafgen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Kim, MD
Role: STUDY_DIRECTOR
Zafgen, Inc.
Locations
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University of California, Davis
Sacramento, California, United States
UCSD: Rady Children's Hospital
San Diego, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Kansas University Medical Center
Kansas City, Kansas, United States
National Institute of Child Health
Bethesda, Maryland, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Children's Hospital and Clinics of Minnesota
Saint Paul, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Winthrop University
Mineola, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Research Institute
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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ZAF-311
Identifier Type: -
Identifier Source: org_study_id
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