An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-Blind, Placebo Controlled, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an Optional 4-Week Open-Label Extension

Conditions
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Obesity, Over-weight, Hypothalamic Injury, Craniopharyngioma

Intervention / Treatment
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* Drug: ZGN-440 sterile diluent
* Drug: ZGN-440 for injectable suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2 Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary Stable body weight for at least 3 months Type 2 diabetes mellitus is allowed Exclusion Criteria: Males taking gonadotropin replacement therapy (LH/FSH) Subjects who are planning any fertility treatment within 6 months of study participation Use of weight loss agents, including herbal medications, in the past 3 months Current or anticipated chronic use of narcotics or opiates History of severe psychiatric disorders Type 1 diabetes mellitus Metabolic disorders or genetic disorders linked to obesity History of any bariatric surgery Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study Blood loss or donation >500 mL within the past 3 months Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: ZGN-440 sterile diluent<br>Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks. | Drug: ZGN-440 sterile diluent<br>* ZGN-440 sterile diluent/placebo<br>* Other names: Placebo;|
| Experimental: ZGN-440 for injectable suspension<br>Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. | Drug: ZGN-440 for injectable suspension<br> <br> * Other names: Beloranib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline to the end of the randomized dosing period. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433