NCT03298464已完成1 期
A Phase 1B, Single Center, Randomized, Open Label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single NGM313 Dose or Daily Oral Pioglitazone in Obese Participants With Insulin Resistance and Increased Liver Fat
NGM Biopharmaceuticals, Inc1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年9月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration
研究概览
简要总结
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of 30-43 kg/m2
- •Waist circumference > 40 inches in males or > 30 inches in females
- •Normal ECG readings
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
- •History of any known Congestive heart failure (CHF)
- •History of macrovascular disease
研究组 & 干预措施
Pioglitazone
Active Comparator
干预措施: Pioglitazone (Drug)
NGM313
Experimental
干预措施: NGM313 (Biological)
结局指标
主要结局
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration
时间窗: 28 Days
次要结局
未报告次要终点
研究者
研究点 (1)
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