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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Prader-Willi Syndrome, Obesity

Intervention / Treatment
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* Drug: ZGN-440 for Injectable Suspension
* Drug: ZGN-440 Placebo for Injectable Suspension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intervention: ZGN-440 Placebo for Injectable Suspension | Drug: ZGN-440 Placebo for Injectable Suspension<br>* Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.<br>* Other names: Placebo;|
| Experimental: ZGN-440 Injectable Suspension (1.8 mg)<br>Intervention: ZGN-440 for Injectable Suspension | Drug: ZGN-440 for Injectable Suspension<br>* Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.<br>* Other names: Beloranib;|
| Experimental: ZGN-440 Injectable Suspension (2.4 mg)<br>Intervention: ZGN-440 for Injectable Suspension | Drug: ZGN-440 for Injectable Suspension<br>* Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.<br>* Other names: Beloranib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Prader-Willi Syndrome, Hyperphagia