Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

Detailed Description
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This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Official Title
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Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers

Conditions
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Obesity

Intervention / Treatment
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* Drug: ZGN-433
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese but otherwise healthy females Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months) BMI ≥ 30 and ≤ 50 kg/m2 Stable body weight during the past month Exclusion Criteria: Use of weight loss agents in the past month History of eating disorder History of gastric bypass surgery Current smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Normal Saline<br> | Drug: Normal Saline<br>* Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.<br>|
| Experimental: ZGN-433<br> | Drug: ZGN-433<br>* Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.<br>* Other names: Beloranib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers. | Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests. | Approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability. |  | Approximately 4 weeks | 
| Peak plasma concentration of ZGN-433 to assess relationship to weight loss. |  | Approximately 4 weeks | 
| Elimination half-life of ZGN-433 to assess relationship to weight loss. |  | Approximately 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Obesity, Overweight