Randomized, Double-Blind, Placebo Controlled, Dose Ranging Phase 2 Trial of Beloranib (ZGN-440 for Injectable Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects to Evaluate Weight Reduction, Safety, and Pharmacokinetics Over 12 Weeks
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Obesity
- Sponsor
- Zafgen, Inc.
- Enrollment
- 160
- Locations
- 3
- Primary Endpoint
- Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.
Detailed Description
This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Obese volunteers weighing ≥ 50 kg
- •BMI ≥ 30 and ≤ 50 kg/m2
- •Stable body weight during the past 2 months
- •Type 2 diabetes mellitus is allowed
Exclusion Criteria
- •Use of weight loss agents in the past month
- •Current, clinically significant eating disorder
- •Type 1 diabetes mellitus
Arms & Interventions
Placebo
ZGN-440 sterile diluent
Intervention: Placebo
0.3 mg Beloranib
0.3 mg ZGN-440 for injectable suspension
Intervention: Beloranib
0.6 mg Beloranib
0.6 mg ZGN-440 for injectable suspension
Intervention: Beloranib
1.2 mg Beloranib
1.2 mg ZGN-440 for injectable suspension
Intervention: Beloranib
2.4 mg Beloranib
2.4 mg ZGN-440 for injectable suspension
Intervention: Beloranib
3.2 mg Beloranib
3.2 mg ZGN-440 for injectable suspension
Intervention: Beloranib
Outcomes
Primary Outcomes
Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
Time Frame: Up to 26 weeks
Safety and tolerability of beloranib will be assessed by comparing frequency and severity of adverse events as well as changes in physical examinations, ECGs, vital signs and laboratory evaluations. Other safety oriented questionnaires and parameters (e.g. sleep quality, hemodynamic parameters) will be measured and evaluated.
Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440
Time Frame: Up to 13 weeks
Change from baseline in body weight and body composition (bioimpedance assessments), and scores of hunger/appetite over the dosing period will be evaluated to document beloranib's effect on obesity. Biomarkers of lipid metabolism will be measured to assess possible mechanisms of loss of body fat, as well as endocrinologic or anti-inflammatory markers.
Secondary Outcomes
- Pharmacodynamics over a dose range of beloranib(Up to 12 weeks)
- Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously(Up to 12 weeks)
- Apparent bioavailability over a dose range of beloranib(Up to 12 weeks)