NCT02708576已完成1 期
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM313 in Healthy Overweight and Obese Adult Participants
NGM Biopharmaceuticals, Inc1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Absolute change in weight in kilograms
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of NGM313, both single dose and multiple doses, in normal healthy overweight and obese adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •BMI range 27-40 kg/m2, inclusive for the SAD module, and 27-40 kg/m2, inclusive for the MAD module;
- •Normal clinical laboratory evaluations
- •Normal ECG findings
排除标准
- •Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- •Uncontrolled hypertension defined as sitting blood pressure systolic > 150 mm/Hg and/or diastolic > 90 mm/Hg
研究组 & 干预措施
Placebo
Placebo Comparator
Administration of placebo comparator
干预措施: Placebo (Other)
NGM313
Experimental
Administration of active NGM313
干预措施: NGM313 (Biological)
结局指标
主要结局
Absolute change in weight in kilograms
时间窗: 28 and 84 days
次要结局
- Absolute change in fasting glucose in mmol/L(28 and 84 days)
研究者
研究点 (1)
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