NCT04187339已完成1 期
A Phase 1, Randomized, Placebo-controlled, Double-blind, Two-part Study to Evaluate the Safety and Tolerability of NGM395 in Adult Obese Patients (Part 1) and in Adult Patients With Nonalcoholic Fatty Liver Disease (NAFLD) (Part 2).
NGM Biopharmaceuticals, Inc1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年2月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
Study of NGM395 in adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.
- •Liver fat ≥8% as assessed by MRI-PDFF.
- •BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
- •Waist circumference > 40 inches for males or > 35 inches for females.
排除标准
- •Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.
- •Subjects with T2D managed with diet alone with HbA1c level > 6.5% or fasting glucose ≥ 126 mg/dL at Screening.
- •History of bariatric surgery.
- •Fasting triglycerides > 400 mg/dL at Screening.
- •Diagnosed with type 2 diabetes with a HbA1c >9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.
结局指标
主要结局
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
时间窗: 140 Days
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
次要结局
- Serum Concentration of NGM395(140 Days)
研究者
研究点 (1)
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