A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as Well as in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Terns, Inc.
- 入组人数
- 162
- 试验地点
- 35
- 主要终点
- Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
研究概览
简要总结
This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)
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 diagnosed by prior biopsy and/or imaging criteria
- •Written informed consent
排除标准
- •History or clinical evidence of chronic liver diseases other than NAFLD
- •History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
- •History of liver transplant, or current placement on a liver transplant list
- •Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
- •Abnormal TSH or free T4 levels
- •Weight loss of > 5% total body weight within 3 months prior to Screening
- •Uncontrolled diabetes
- •Uncontrolled hyperlipidemia
- •Unstable cardiovascular disease
- •Excessive alcohol consumption
- •Other protocol-defined I/E criteria that apply.
研究组 & 干预措施
Arm 1: TERN-501 1 mg
Orally administered.
干预措施: TERN-501 (Drug)
Arm 2: TERN-501 3 mg
Orally administered.
干预措施: TERN-501 (Drug)
Arm 3: TERN-501 6 mg
Orally administered.
干预措施: TERN-501 (Drug)
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
干预措施: TERN-501 (Drug)
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
干预措施: TERN-101 (Drug)
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
干预措施: TERN-501 (Drug)
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
干预措施: TERN-101 (Drug)
Arm 6:TERN-101 10 mg
Orally administered.
干预措施: TERN-101 (Drug)
Arm 7: Matching placebo
Orally administered.
干预措施: Placebo (Other)
结局指标
主要结局
Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
时间窗: 12 weeks
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
次要结局
- Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo(12 weeks)
- Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo(12 weeks)
- Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo(12 weeks)
- Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)(16 weeks)