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FDA Clinical Hold
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intervention: ZGN-440 Placebo for Injectable Suspension |
|
| ZGN-440 Injectable Suspension (1.8 mg) | Experimental | Intervention: ZGN-440 for Injectable Suspension |
|
| ZGN-440 Injectable Suspension (2.4 mg) | Experimental | Intervention: ZGN-440 for Injectable Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZGN-440 for Injectable Suspension | Drug | Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in total body weight | Baseline to Week 29 | |
| Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire | Baseline to Week 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL cholesterol | Baseline to Week 29 | |
| Change in HDL cholesterol | Baseline to Week 29 | |
| Change in total body mass as measured by DXA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Kim, MD | Zafgen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States | ||
| UCSD: Rady Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28556449 | Derived | 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. |
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|
| ZGN-440 Placebo for Injectable Suspension | Drug | Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks. |
|
|
| Baseline to Week 29 |
| Change in total body fat mass as measured by DXA | Baseline to Week 29 |
| Change in triglyceride | Baseline to Week 29 |
| 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 | Saint 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 |
| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| D009765 | Obesity |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C487952 | CKD732 |
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