NCT04773964已完成2 期
Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)
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
- 215
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
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
- •Diagnosis of NASH via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE, FibroScan)
- •Liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).
排除标准
- •History of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant.
- •Presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis).
- •Excessive consumption of alcohol.
研究组 & 干预措施
MET642 high dose
Experimental
干预措施: MET642 (Drug)
MET642 low dose
Experimental
干预措施: MET642 (Drug)
MET642 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 28 days after last dose
Incidences of treatment-emergent adverse events
Vital Signs
时间窗: Up to 28 days after last dose
Incidences of clinically significant changes in vital signs
ECG
时间窗: Up to 28 days after last dose
Incidences of clinically significant changes in ECGs
Laboratory tests
时间窗: Up to 28 days after last dose
Incidences of clinically significant changes in laboratory tests
次要结局
- Pharmacokinetic Profile of MET642(16 weeks)
- Pharmacodynamic Profile of MET642(16 weeks)
- Pharmacological Activity of MET642(20 weeks)
研究者
研究点 (1)
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