NCT04328077已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Terns, Inc.
- 入组人数
- 101
- 试验地点
- 31
- 主要终点
- Number of Participants With Adverse Events for TERN-101 Versus Placebo
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.
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
- Triple (Participant, Care Provider, Investigator)
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 PDFF liver fat content ≥ 10 %
- •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
- •Total bilirubin > 1.2 mg/dL
- •Albumin < 3.5 g/dL
- •INR > 1.1
- •AST or ALT > 5 x ULN
- •ALP > 156 IU/L
- •Platelet count < 150,000 /mm3
- •eGFR < 60 mL/min/1.73m2
- •Weight loss > 5% within past 3 months prior to Screening
- •Uncontrolled diabetes
- •Uncontrolled hyperlipidemia
- •Active COVID-19 infection
- •Other protocol-defined inclusion/exclusion criteria could apply
研究组 & 干预措施
TERN-101 dose level 1
Experimental
Orally administered.
干预措施: TERN-101 (Drug)
TERN-101 dose level 2
Experimental
Orally administered.
干预措施: TERN-101 (Drug)
TERN-101 dose level 3
Experimental
Orally administered.
干预措施: TERN-101 (Drug)
Placebo
Placebo Comparator
Orally administered.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With Adverse Events for TERN-101 Versus Placebo
时间窗: 16 weeks
次要结局
- Percent Change From Baseline in ALT Outcome Measure(12 weeks)
- Plasma Concentration of TERN-101 - Cmax(12 Weeks (0-72 hours post dose))
- Plasma Concentration of TERN-101 - AUC 0-24(12 weeks (0-24 hours post dose))
- Plasma Concentration of TERN-101 - Tmax(12 Weeks (0-72 hours post dose))
- Plasma Concentration of TERN-101 - t1/2(12 Weeks (0-72 hours post dose))
研究者
研究点 (31)
Loading locations...
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