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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Zafgen, Inc.
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
研究概览
简要总结
The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.
详细描述
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.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Use of weight loss agents in the past month
- •History of eating disorder
- •History of gastric bypass surgery
- •Current smokers
研究组 & 干预措施
Normal Saline
干预措施: Normal Saline (Drug)
ZGN-433
干预措施: ZGN-433 (Drug)
结局指标
主要结局
Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
时间窗: Approximately 4 weeks
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.
次要结局
- 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)