A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 28
- 主要终点
- Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-lactating females
- •Evidence of NASH with fibrosis on biopsy
排除标准
- •Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)
- •Other causes of liver disease including viral hepatitis and alcoholic liver disease
- •Any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
- •History of liver transplantation
- •Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1 oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine, and a 1 oz/30 mL measure of 40% proof alcohol)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
SEL 6 mg
Selonsertib (SEL) 6 mg for 24 weeks.
干预措施: SEL (Drug)
SEL 18 mg
SEL 18 mg for 24 weeks.
干预措施: SEL (Drug)
SEL 6 mg+SIM 125 mg
SEL 6 mg plus SIM 125 mg for 24 weeks.
干预措施: SEL (Drug)
SEL 6 mg+SIM 125 mg
SEL 6 mg plus SIM 125 mg for 24 weeks.
干预措施: SIM (Biological)
SEL 18 mg+SIM 125 mg
SEL 18 mg plus SIM 125 mg for 24 weeks.
干预措施: SEL (Drug)
SEL 18 mg+SIM 125 mg
SEL 18 mg plus SIM 125 mg for 24 weeks.
干预措施: SIM (Biological)
SIM 125 mg
SIM 125 mg for 24 weeks.
干预措施: SIM (Biological)
结局指标
主要结局
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality
时间窗: Baseline up to last dose plus 30 days (up to Week 28)
Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events
时间窗: Baseline up to follow up visit (Week 28)
次要结局
未报告次要终点