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



Status:Terminated
Conditions:Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:12 - 65
Updated:12/16/2016
Start Date:September 2014
End Date:October 2016

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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.

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

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
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Gainesville, Florida 32610
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Bethesda, Maryland 20892
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Boston, Massachusetts 02115
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Kansas City, Kansas
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Mineola, New York 11501
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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San Diego, California 92123
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Seattle, Washington 98105
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221 N Grand Blvd
St. Louis, Missouri 63103
(800) 758-3678
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