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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Zafgen, Inc.
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Use of weight loss agents in the past month
- •Current, clinically significant eating disorder
- •Type 1 diabetes mellitus
研究组 & 干预措施
Placebo
ZGN-440 sterile diluent
干预措施: Placebo (Drug)
0.3 mg Beloranib
0.3 mg ZGN-440 for injectable suspension
干预措施: Beloranib (Drug)
0.6 mg Beloranib
0.6 mg ZGN-440 for injectable suspension
干预措施: Beloranib (Drug)
1.2 mg Beloranib
1.2 mg ZGN-440 for injectable suspension
干预措施: Beloranib (Drug)
2.4 mg Beloranib
2.4 mg ZGN-440 for injectable suspension
干预措施: Beloranib (Drug)
3.2 mg Beloranib
3.2 mg ZGN-440 for injectable suspension
干预措施: Beloranib (Drug)
结局指标
主要结局
Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
时间窗: 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
时间窗: 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.
次要结局
- 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)