A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 89bio, Inc.
- 入组人数
- 762
- 试验地点
- 335
- 主要终点
- Proportion of Participants Achieving Fibrosis Regression
研究概览
简要总结
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
- •Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
- •Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
- •Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2).
排除标准
- •Liver disorder other than MASH.
- •History or evidence of hepatic decompensation.
- •History or evidence of hepatocellular carcinoma.
- •Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
- •ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
- •Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening.
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
Matched placebo
干预措施: Placebo (Drug)
Pegozafermin
干预措施: Pegozafermin (Biological)
结局指标
主要结局
Proportion of Participants Achieving Fibrosis Regression
时间窗: Baseline through Month 24
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Proportion of Participants Achieving Fibrosis Regression
时间窗: Baseline through Month 24
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
时间窗: Baseline up to 5 years
次要结局
- Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)(Baseline up to Month 60)
- Change from Baseline in Enhanced Liver Fibrosis (ELF) Score(Baseline, up to Month 60)
- Change from Baseline in Alanine Aminotransferase (ALT) Level(Baseline, up to Month 60)
- Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)(Baseline, up to Month 60)
- Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)(Baseline up to Month 60)