A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Terns, Inc.
- 入组人数
- 52
- 试验地点
- 11
- 主要终点
- Treatment-Emergent Laboratory Abnormalities
研究概览
简要总结
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years of age
- •Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
- •Presumed NASH based on clinical characteristics or prior liver biopsy
- •ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
- •MRI-cT1 value> 800 ms
- •Written informed consent
排除标准
- •History or clinical evidence of chronic liver diseases other than NAFLD
- •History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
- •History of liver transplant, or current placement on a liver transplant list
- •Weight loss of > 5% total body weight within 3 months prior to Screening
- •Note: Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
TERN-201 10mg
Orally administered
干预措施: TERN-201 (Drug)
TERN-201 20mg
Orally Administered
干预措施: TERN-201 (Drug)
Placebo
Orally administered
干预措施: Placebo (Other)
结局指标
主要结局
Treatment-Emergent Laboratory Abnormalities
时间窗: Day 1 through Week 16
Number of patients with any worsening of ≥ 2 NCI CTCAE Grades in each laboratory assessment category. CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute; laboratory abnormalities were classified according to NCI CTCAE, version 5, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening
Patient Incidence of Adverse Events for TERN-201 Versus Placebo
时间窗: Day 1 through Week 16
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
次要结局
未报告次要终点