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The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZGN-440 sterile diluent | Placebo Comparator | Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks. |
|
| 1.2 mg ZGN-440 for injectable suspension | Experimental | Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. |
|
| 1.8 mg ZGN-440 for injectable suspension | Experimental | Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZGN-440 sterile diluent | Drug | ZGN-440 sterile diluent/placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from baseline to the end of the randomized dosing period. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (kg) from baseline to the end of the randomized dosing period | 4 weeks | |
| Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Miller, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610-0296 | United States |
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| 1.2 mg ZGN-440 for injectable suspension | Drug | 1.2 mg beloranib |
|
|
| 1.8 mg ZGN-440 for injectable suspension | Drug | 1.8 mg beloranib |
|
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| 4 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C487952 | CKD732 |
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