Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 9
- 主要终点
- Change From Baseline in Enhanced Liver Fibrosis Score at Week 48
研究概览
简要总结
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
详细描述
The study will compare multiple doses of aldafermin against placebo in a compensated NASH cirrhosis population for 48 weeks of treatment.
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
- •Liver biopsy consistent with NASH cirrhosis.
- •Compensated cirrhosis due to NASH.
排除标准
- •Other causes of liver disease including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, primary biliary cirrhosis, drug-induced hepatotoxicity, Wilson's disease, hemochromatosis, and alpha-1-anti-trypsin definition based on medical history and/or centralized read of liver histology.
- •Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis.
- •History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy.
- •Model of end stage liver disease (MELD) score >
- •Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Daily 0.3 mg dose
Administered by subcutaneous injection
干预措施: aldafermin (Biological)
Daily 1 mg dose
Administered by subcutaneous injection
干预措施: aldafermin (Biological)
Daily 3 mg dose
Administered by subcutaneous injection
干预措施: aldafermin (Biological)
Placebo
Administered by subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48
时间窗: 48 weeks
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.
次要结局
未报告次要终点