A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 37
- 主要终点
- Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic 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
- 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 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 kilopascal (kPa) OR
- •A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
- •No documented weight loss > 5% between the date of the liver biopsy and screening.
- •Platelet count ≥ 150,000/mm^3
- •Albumin ≥ 3.3 g/dL
- •Serum creatinine ≤ upper limit of normal (ULN)
排除标准
- •Pregnant or lactating females
- •Alanine aminotransferase (ALT) > 5x 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
- •Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)
- •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
GS-9674 30 mg
GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
干预措施: GS-9674 (Drug)
GS-9674 30 mg
GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
干预措施: Placebo to match GS-9674 (Drug)
GS-9674 100 mg
GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
干预措施: GS-9674 (Drug)
GS-9674 100 mg
GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
干预措施: Placebo to match GS-9674 (Drug)
Placebo
Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
干预措施: Placebo to match GS-9674 (Drug)
结局指标
主要结局
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 24 weeks plus 30 days
TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
时间窗: Up to 24 weeks plus 30 days
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.
次要结局
未报告次要终点