A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)

February 27, 2026 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Combination product: Efinopegdutide
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
Other Names:
  • MK-6024
Placebo Comparator: 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.
Combination product: Placebo
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Liver Fat Content (LFC) at Week 28
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Time Frame: 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 Propeptide of Type III Collagen (Pro-C3) at Week 28
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

August 6, 2026

Study Completion (Estimated)

August 6, 2026

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6024-017
  • MK-6024-017 (Other Identifier: MSD)
  • jRCT2031240217 (Registry Identifier: jRCT)
  • U1111-1302-7589 (Registry Identifier: UTN)
  • 2024-510923-20-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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