A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 89bio, Inc.
- 入组人数
- 1,350
- 试验地点
- 382
- 主要终点
- Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52
研究概览
简要总结
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
- •Biopsy-confirmed MASH with fibrosis stage F2 or F3
- •Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants).
排除标准
- •Chronic liver diseases other than MASH
- •Evidence of cirrhosis on screening liver biopsy
- •Have type 1 diabetes or poorly controlled type 2 diabetes
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
- •Participants taking vitamin E (>400 international units [IU]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Pegozafermin Regimen 1
干预措施: Pegozafermin (Biological)
Pegozafermin Regimen 2
干预措施: Pegozafermin (Biological)
Placebo
Matched Placebo will be administered in Regimens 1 and 2.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52
时间窗: Week 52
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52
时间窗: Week 52
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Time to First Occurrence of Disease Progression
时间窗: Up to 5 years
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
次要结局
- Percent Change from Baseline in Alanine Aminotransferase at Week 52(Baseline, Week 52)
- Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52(Baseline, Week 52)