NCT03676231终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SGM-1019 Administered for 12 Weeks in Subjects With F1-F3 Nonalcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 10
- 主要终点
- Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) 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
- •Male or female
- •Age 18 to 75 years, inclusive
- •Elevated ALT
- •F1-F3 NASH
排除标准
- •Use of prohibited medication/supplements
- •Poorly controlled type 2 diabetes
- •Hepatic decompensation
- •Chronic liver disease
- •Planned surgeries/procedures
研究组 & 干预措施
High-dose SGM-1019
Experimental
干预措施: SGM-1019 (Drug)
Low-dose SGM-1019
Experimental
干预措施: SGM-1019 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
时间窗: 12 weeks
Summary of treatment emergent adverse events coded using MedDRA
次要结局
- Evaluation of Pharmacodynamics - Labs(12 weeks)
- Evaluation of Pharmacokinetics - PK(12 weeks)
- Evaluation of Phamacodynamics - MRI(12 weeks)
研究者
研究点 (10)
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