A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)
试验速览
- 阶段
- 2 期
- 入组人数
- 273
- 试验地点
- 69
- 主要终点
- Improvement in steatohepatitis
研究概览
简要总结
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and provide written informed consent.
- •Male and female adults aged > 18 years.
- •Must have NASH and fibrosis on a liver biopsy sample
- •If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening;
- •Subjects may have a diagnosis of T2DM
排除标准
- •History or presence of liver disease (other than NAFLD or NASH)
- •History or presence of cirrhosis and/or history or presence of hepatic decompensation
研究组 & 干预措施
AXA1125 22.6g
22.6 g AXA1125 administered orally BID with or without food
干预措施: AXA1125 (Drug)
AXA1125 33.9g
33.9 g AXA1125 administered orally BID with or without food
干预措施: AXA1125 (Drug)
Placebo
Matching Placebo administered orally BID with or without food
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in steatohepatitis
时间窗: Baseline to Week 48
2-point improvement from baseline to Week 48 in the non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) based on a scale from 0-8 with 0 being no NASH and 8 being the highest score
次要结局
- Resolution of NASH without worsening of fibrosis(Baseline to week 48)
- Improvement of fibrosis by one stage without worsening of NASH(Baseline to week 48)
- Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)(Baseline to week 48)
- Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)(Baseline to week 48)
- Change from baseline in hepatic fat as measured by MRI(Baseline to week 48)
- Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)(Baseline to week 48)