NCT05305599已完成2 期
Double-blind, Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of ZED1227 Capsules With Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) With Significant Fibrosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Relative change of PRO-C3 levels
研究概览
简要总结
This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.
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, Care Provider, Investigator)
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
- •Has provided signed informed consent
- •Is a male or female ≥ 18 and < 75 years of age
- •Has diagnosed NAFLD
- •Has diagnosed significant fibrosis (stages 2 or 3)
排除标准
- •Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males)
- •Has a history or presence of any other significant concomitant liver diseases
- •Has diagnosed type 1 diabetes mellitus (T1DM)
- •Has presence of cirrhosis
研究组 & 干预措施
ZED1227 (low dose) 10 mg
Experimental
干预措施: ZED1227 (Drug)
ZED1227 (middle dose) 25 mg
Experimental
干预措施: ZED1227 (Drug)
ZED1227 (high dose) 50 mg
Experimental
干预措施: ZED1227 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Relative change of PRO-C3 levels
时间窗: 12 weeks
Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.
次要结局
- Incidence of adverse events(from baseline to 16 weeks)
研究者
研究点 (1)
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