NCT02923154已完成2 期
An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Percent change from baseline in ALT
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with 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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with NASH before randomization
- •Subjects who conducts diet or exercise therapy at the beginning of run in period.
- •Subjects who has given full and adequate information of the protocol and with written informed consent
排除标准
- •Subjects with hepatic failure or previously diagnosed with hepatic cirrhosis
- •Subjects with alcohol dependence or previously diagnosed with alcohol dependence
- •Subjects with other chronic liver disease (e.g., primary sclerosing cholangitis, alcoholic liver damage, hemochromatosis, Wilson's disease)
- •Presence, history, or family history of long QT syndrome or Torsades de Pointes
- •Subjects with heart failure (New York Heart Association Class III-IV)
研究组 & 干预措施
MT-3995
Experimental
干预措施: MT-3995 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in ALT
时间窗: 24 weeks
次要结局
- Adverse events(From baseline to 72 weeks)
- Change from baseline in ALT(24 weeks)
研究者
研究点 (1)
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