NCT06920043招募中2 期
A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 63
- 主要终点
- Number of participants with treatment emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 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
- Double (Participant, 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
- •Ability to understand and sign a written informed consent form (ICF)
- •Age 18 through 75 years at enrollment
- •History or presence of 2 or more of the 5 components of metabolic syndrome
- •Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
- •Other inclusion criteria may apply.
排除标准
- •Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
- •History of type 1 diabetes
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
- •Other exclusion criteria may apply.
研究组 & 干预措施
Efimosfermin (Dose 1)
Experimental
Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).
干预措施: Efimosfermin (Drug)
Efimosfermin (Dose 2)
Experimental
Participants will receive efimosfermin (Dose 2) Q4W.
干预措施: Efimosfermin (Drug)
Placebo
Placebo Comparator
Participants will receive placebo Q4W.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events (TEAEs)
时间窗: From Day 1 to 100 weeks
To assess the effects of efimosfermin on safety and tolerability.
次要结局
- Serum concentrations of efimosfermin(Up to Week 21)
- Maximum serum drug concentration (Cmax) of efimosfermin(Up to Week 21)
- Area under the serum concentration-time curve (AUC) of efimosfermin(Up to Week 21)
- Average serum drug concentration (Cavg) of efimosfermin(Up to Week 21)
- Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin(Up to Week 21)
研究者
研究点 (63)
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