A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Zafgen, Inc.
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.
详细描述
This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.
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, otherwise healthy females
- •Post menopausal or infertile
- •Weight ≥ 50 kg
- •BMI ≥ 32 and ≤ 45 kg/m2
排除标准
- •Use of weight loss agents in the past month
- •History of eating disorder
- •History of diabetes or other endocrine disorder
- •History of gastric bypass
- •Current smokers
- •Unstable body weight during the past 3 months
研究组 & 干预措施
ZGN-433
干预措施: ZGN-433 (Drug)
Normal Saline
干预措施: ZGN-433 (Drug)
结局指标
主要结局
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.
时间窗: Approximately 2 months
次要结局
- Weight(Approximately 2 months)