A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 53
- 主要终点
- Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
研究概览
简要总结
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with 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
- Double (Participant, Care Provider)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants will receive a fixed dose of placebo matched to BFKB8488A.
干预措施: Placebo (Drug)
Fixed Dose: BFKB8488A Dose A
Participants will receive BFKB8488A.
干预措施: BFKB8488A (Drug)
Fixed Dose: BFKB8488A Dose B
Participants will receive BFKB8488A.
干预措施: BFKB8488A (Drug)
Fixed Dose: BFKB8488A Dose C
Participants will receive BFKB8488A.
干预措施: BFKB8488A (Drug)
结局指标
主要结局
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
时间窗: Week 52
Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader.
次要结局
- Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52(Week 52)
- Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52(Baseline, Week 16, Week 52)
- Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52(Week 52)