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The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZGN-440 sterile diluent | Placebo Comparator | Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks. |
|
| 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 |
|---|---|---|
| Change in body weight from baseline to the end of the randomized dosing period. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period | 4 weeks | |
| Change in hs-CRP from baseline to the end of the randomized dosing period. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | 55102 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28261955 | Derived | Shoemaker A, Proietto J, Abuzzahab MJ, Markovic T, Malloy J, Kim DD. A randomized, placebo-controlled trial of beloranib for the treatment of hypothalamic injury-associated obesity. Diabetes Obes Metab. 2017 Aug;19(8):1165-1170. doi: 10.1111/dom.12928. Epub 2017 Apr 18. |
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| ZGN-440 for injectable suspension | Drug |
|
|
| Change in hunger from baseline to the end of the randomized dosing period. | 4 weeks |
| Change in quality of life from baseline to the end of the randomized dosing period. | 4 weeks |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| The Boden Institute | Sydney | New South Wales | 2006 | Australia |
| Austin Health, Metabolic Disorders Centre | Heidelberg Heights | Victoria | 3081 | Australia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003397 | Craniopharyngioma |
| 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 |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C487952 | CKD732 |
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