A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (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
- Double (Participant, 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
- •Meets all of the following conditions:
- •A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
- •Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
- •Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa
- •A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis
- •Platelet count ≥ 100,000/mm^3
- •Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min
排除标准
- •Pregnant or lactating females
- •Alanine aminotransferase (ALT) > 5 x upper limit of the normal range (ULN)
- •Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
- •Cirrhosis of the liver
- •Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
- •Body mass index (BMI) < 18 kg/m^2
- •International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
- •Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Firsocostat 5 mg
Participants will receive firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
干预措施: Firsocostat (Drug)
Firsocostat 5 mg
Participants will receive firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
干预措施: Placebo (Drug)
Firsocostat 20 mg
Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.
干预措施: Firsocostat (Drug)
Firsocostat 20 mg
Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.
干预措施: Placebo (Drug)
Placebo
Participants will receive 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
时间窗: First Dose date up to last dose (Week 12) plus 30 days
次要结局
未报告次要终点