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艾芬哌杜肽治疗脂肪性肝炎代偿性肝硬化患者的临床研究 (MK-6024-017)

2026年9月17日 更新者：Merck Sharp & Dohme LLC

2a 期随机、双盲、安慰剂对照研究，旨在评估 Efinopegdutide (MK-6024) 对继发于代谢功能障碍相关脂肪性肝炎的代偿性肝硬化成人的疗效和安全性

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

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

85

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Haifa、以色列、3109601
        • Rambam Health Care Campus ( Site 0801)
      • Haifa、以色列、3436212
        • Carmel Hospital-Liver Unit ( Site 0802)
      • Jerusalem、以色列、9103102
        • Shaare Zedek Medical Center ( Site 0805)
      • Petah Tikva、以色列、4925110
        • Maccabi Health Services - Petah Tikva ( Site 0804)
      • Tel Aviv、以色列、6789140
        • Assuta Medical Center ( Site 0806)
  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2C4
        • Toronto General Hospital ( Site 0207)
    • Quebec
      • Québec、Quebec、加拿大、G1V 4T3
        • Diex Recherche Quebec ( Site 0204)
  • 哥伦比亚
    • Cundinamarca
      • Bogotá、Cundinamarca、哥伦比亚、110111
        • Fundacion Santa Fe de Bogota ( Site 0403)
    • Valle del Cauca Department
      • Cali、Valle del Cauca Department、哥伦比亚、760032
        • Fundación Valle del Lili ( Site 0402)
  • 日本
      • Kyoto、日本、602-8566
        • University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
      • Osaka、日本、545-8586
        • Osaka Metropolitan University Hospital ( Site 1403)
      • Saga、日本、849-8501
        • Saga University Hospital ( Site 1405)
    • Kanagawa
      • Kawasaki、Kanagawa、日本、215-0026
        • Shinyurigaoka General Hospital ( Site 1401)
      • Yokohama、Kanagawa、日本、236-0004
        • Yokohama City University Hospital ( Site 1402)
  • 法国
    • Alpes-Maritimes
      • Nice、Alpes-Maritimes、法国、06202
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704)
    • Aquitaine
      • Pessac、Aquitaine、法国、33600
        • CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)
    • Auvergne-Rhône-Alpes
      • Lyon、Auvergne-Rhône-Alpes、法国、69004
        • Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)
    • Hauts-de-Seine
      • Clichy、Hauts-de-Seine、法国、92110
        • Hôpital Beaujon-Hépatologie ( Site 0703)
    • Limousin
      • Limoges、Limousin、法国、87042
        • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
  • 波多黎各
      • Guaynabo、波多黎各、00968
        • ISIS CLINICAL RESEARCH CENTER ( Site 0606)
      • San Juan、波多黎各、00909
        • Klinical Investigations Group-Clinical Research ( Site 0601)
  • 泰国
    • Bangkok
      • Bangkok、Bangkok、泰国、10330
        • Chulalongkorn University ( Site 1301)
      • Bangkok、Bangkok、泰国、10700
        • Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
  • 澳大利亚
    • South Australia
      • Adelaide、South Australia、澳大利亚、5042
        • Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
    • Victoria
      • Melbourne、Victoria、澳大利亚、3065
        • St Vincent's Hospital-Gastroenterology Department ( Site 1205)
  • 美国
    • Arizona
      • Chandler、Arizona、美国、85224
        • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
      • Flagstaff、Arizona、美国、86001
        • Arizona Clinical Trials ( Site 0158)
      • Peoria、Arizona、美国、85381
        • The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
      • Tucson、Arizona、美国、85712
        • The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
    • California
      • Pasadena、California、美国、91105
        • California Liver Research Institute ( Site 0113)
      • San Diego、California、美国、92120
        • Acclaim Clinical Research ( Site 0137)
      • Van Nuys、California、美国、91405
        • Velocity Clinical Research, Panorama City ( Site 0124)
    • Colorado
      • Littleton、Colorado、美国、80120
        • Rocky Mountain Gastroenterology ( Site 0127)
    • Florida
      • Bradenton、Florida、美国、34209
        • Synergy Healthcare ( Site 0118)
      • Homestead、Florida、美国、33033
        • Homestead Associates in Research, Inc. ( Site 0139)
      • Lakewood Rch、Florida、美国、34211
        • Florida Research Institute ( Site 0116)
      • Miami Lakes、Florida、美国、33016
        • Floridian Clinical Research, LLC ( Site 0109)
    • Georgia
      • Dalton、Georgia、美国、30720
        • Southeast Clinical Research Center ( Site 0119)
    • Louisiana
      • Bastrop、Louisiana、美国、71220
        • Delta Research Partners ( Site 0160)
      • Shreveport、Louisiana、美国、71105
        • Louisiana Research Center ( Site 0161)
    • Maryland
      • Glen Burnie、Maryland、美国、21061
        • Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
      • Rockville、Maryland、美国、20854
        • Velocity Clinical Research Rockville ( Site 0143)
    • Michigan
      • Ypsilanti、Michigan、美国、48197
        • Huron Gastroenterology ( Site 0102)
    • Nevada
      • Las Vegas、Nevada、美国、89101
        • The Machuca Foundation ( Site 0115)
      • Las Vegas、Nevada、美国、89109
        • Excel Clinical Research, LLC ( Site 0101)
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • Southwest Gastroenterology Associates ( Site 0129)
    • North Carolina
      • Fayetteville、North Carolina、美国、28304
        • Coastal Research Institute - Fayetteville ( Site 0159)
      • Morehead City、North Carolina、美国、28557
        • Lucas Research, Inc ( Site 0105)
    • Texas
      • Arlington、Texas、美国、76012
        • Texas Clinical Research Institute ( Site 0126)
      • Austin、Texas、美国、78757
        • Pinnacle Clinical Research ( Site 0104)
      • Corpus Christi、Texas、美国、78404
        • Pinnacle Clinical Research-Corpus Christi ( Site 0156)
      • Dallas、Texas、美国、75230
        • Zenos Clinical Research ( Site 0136)
      • Fort Worth、Texas、美国、76104
        • GI Alliance Department of Research ( Site 0162)
      • Houston、Texas、美国、77079
        • Houston Research Institute ( Site 0117)
      • Houston、Texas、美国、77004
        • Houston Research Institute ( Site 0172)
      • San Antonio、Texas、美国、78215
        • American Research Corporation ( Site 0131)
      • San Antonio、Texas、美国、78229
        • Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia Health System ( Site 0164)
  • 英国
    • London, City of
      • London、London, City of、英国、SE5 9RL
        • King's College Hospital ( Site 1104)
    • Scotland
      • Aberdeen、Scotland、英国、AB25 2ZN
        • Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
      • Seville、西班牙、41013
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)
    • Cantabria
      • Santander、Cantabria、西班牙、39005
        • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
    • Castille and León
      • Valladolid、Castille and León、西班牙、47010
        • Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)
    • Ciudad Real
      • Tomelloso、Ciudad Real、西班牙、13700
        • Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
    • La Coruna
      • A Coruña、La Coruna、西班牙、15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
      • Santiago de Compostela、La Coruna、西班牙、15706
        • CHUS - Hospital Clinico Universitario ( Site 1011)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
组合产品：Efinopegdutide

Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks

其他名称：
  • MK-6024
安慰剂比较：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.
组合产品：Placebo

Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline in Liver Fat Content (LFC) at Week 28
大体时间：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.
Baseline and 28 weeks
Percentage of Participants Who Experienced an Adverse Event (AE)
大体时间：Up to approximately 36 weeks

An AE is a health problem that happens or worsens during the study
Up to approximately 36 weeks
Percentage of Participants Discontinuing Study Medication Due to an AE
大体时间：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.
Up to approximately 28 weeks

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in Iron-corrected T1 (cT1) at Week 28
大体时间：Baseline and up to 28 Weeks

Researchers will measure the change in liver inflammation and scarring (fibrosis) after about 7 months of treatment.

MRI measurement of cT1 mapping will be used to indicate the amount of liver inflammation and fibrosis. The change in cT1 mapping from baseline to 28 weeks will be presented.
Baseline and up to 28 Weeks
Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28
大体时间：Baseline and up to 28 weeks

Researchers will measure the change in liver scarring using biomarkers. Biomarkers are substances measured in blood that show normal or abnormal activity taking place in the liver.

ELF is calculated using 3 markers of hepatic extracellular matrix turnover to generate a unitless numerical score. The change from baseline in ELF up to 28 weeks will be reported.
Baseline and up to 28 weeks
Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28
大体时间：Baseline and up to 28 weeks

Researchers will measure the change in liver scarring using biomarkers.

Pro-C3 is measured in serum; Increasing levels indicate worsening of fibrosis activity. The change in Pro-C3 from baseline to 28 weeks will be reported.
Baseline and up to 28 weeks
Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28
大体时间：Baseline and up to 28 weeks

Researchers will measure the change in liver scarring using biomarkers.

FIB-4 index is calculated using the participant's age and 3 serum markers (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and platelet count). The change from baseline in FIB-4 after 28 weeks will be reported.
Baseline and up to 28 weeks
Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28
大体时间：Baseline and up to 28 weeks

Researchers will measure the change in liver scarring using ultrasound.

LSM is measured using VCTE. The change from baseline in LSM after 28 weeks will be reported.
Baseline and up to 28 weeks
Percent Change from Baseline in Body Weight at Week 28
大体时间：Baseline and up to approximately 28 weeks

Body weight will be measured using a standardized, digital scale. The percent change from baseline in body weight after 28 weeks will be reported
Baseline and up to approximately 28 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月12日

初级完成 (实际的)

2026年8月3日

研究完成 (实际的)

2026年8月3日

研究注册日期

首次提交

2024年6月13日

首先提交符合 QC 标准的

2024年6月13日

首次发布 (实际的)

2024年6月18日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 6024-017
  • MK-6024-017 (其他标识符：MSD)
  • jRCT2031240217 (注册表标识符：jRCT)
  • U1111-1302-7589 (注册表标识符：UTN)
  • 2024-510923-20-00 (注册表标识符：EU CT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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