An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects
- Registration Number
- NCT01666691
- Lead Sponsor
- Zafgen, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- Use of weight loss agents in the past month
- Current, clinically significant eating disorder
- Type 1 diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo ZGN-440 sterile diluent 0.3 mg Beloranib Beloranib 0.3 mg ZGN-440 for injectable suspension 0.6 mg Beloranib Beloranib 0.6 mg ZGN-440 for injectable suspension 1.2 mg Beloranib Beloranib 1.2 mg ZGN-440 for injectable suspension 2.4 mg Beloranib Beloranib 2.4 mg ZGN-440 for injectable suspension 3.2 mg Beloranib Beloranib 3.2 mg ZGN-440 for injectable suspension
- Primary Outcome Measures
Name Time Method Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks 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 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 Outcome Measures
Name Time Method Pharmacodynamics over a dose range of beloranib Up to 12 weeks The plasma PK of beloranib and selected metabolites may be assessed following dose administration to compare systemic exposure and PK parameters over the range of doses. PK parameters include Cmax, Tmax, AUC24hour, AUC∞, volume of distribution, total clearance, terminal elimination constant, and half-life. Mean residence time may also be reported.
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 Bioavailability will be estimated from the SC PK parameters compared to the profile from comparable doses in earlier IV administration studies.
Trial Locations
- Locations (3)
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Linear Clinical Research Ltd
🇦🇺Perth, Western Australia, Australia
CMAX
🇦🇺Adelaide, South Australia, Australia