Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 68
- 主要终点
- Change from Baseline in Liver Fat Content (LFC) at Week 28
研究概览
简要总结
Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn:
- If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver
- About the safety of efinopegdutide and how well people tolerate it
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
- •Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has history of a liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
- •Has history of type 1 diabetes
- •Had a bariatric surgical procedure less than 5 years before entry into the study
- •History of pancreatitis
- •Major illnesses like recent (within 6 months of study entry) episodes of heart problems, such as congestive heart failure, unstable angina, heart attack, stroke, or mini-stroke
研究组 & 干预措施
Efinopegdutide
Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks.
干预措施: Efinopegdutide (Combination Product)
Placebo
Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.
Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks.
干预措施: Placebo (Combination Product)
结局指标
主要结局
Change from Baseline in Liver Fat Content (LFC) at Week 28
时间窗: Baseline and 28 weeks
Researchers will measure the change in the amount of fat in the liver using magnetic resonance imaging (MRI) after about 7 months of treatment. The change in MRI-Estimated proton density fat fraction (PDFF) will be measured from baseline to 28 weeks.
Percentage of Participants Discontinuing Study Medication Due to an AE
时间窗: Up to approximately 28 weeks
An AE is a health problem that happens or worsens during a study. The percentage of participants who stop study treatment due to an AE will be reported.
Percentage of Participants Who Experienced an Adverse Event (AE)
时间窗: Up to approximately 36 weeks
An AE is a health problem that happens or worsens during the study
次要结局
- Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28(Baseline and up to 28 weeks)
- Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28(Baseline and up to 28 weeks)
- Percent Change from Baseline in Body Weight at Week 28(Baseline and up to approximately 28 weeks)
- Change from Baseline in Iron-corrected T1 (cT1) at Week 28(Baseline and up to 28 Weeks)
- Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28(Baseline and up to 28 weeks)
- Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28(Baseline and up to 28 weeks)