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

NCT06465186 | Active Not Recruiting Phase 2 FDA Drug

• 5 other identifiers: 6024-0172024-510923-20-00MK-6024-017jRCT2031240217U1111-1302-7589
• Study Type: interventional
• Target: 80
• Locations: 11 countries
• Sites: 68

Brief Summary

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

Conditions

Non-alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; NAFLD; Metabolic Dysfunction-associated Steatotic Liver Disease; Metabolic Dysfunction-associated Steatohepatitis

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Liver Fat Content (LFC) at Week 28

  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)

  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

  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 Outcomes (6)

• 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

• 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

Study Arms (2)

Efinopegdutide

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Efinopegdutide COMBINATION_PRODUCT

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

Also known as: MK-6024

Efinopegdutide

Placebo COMBINATION_PRODUCT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (68)

The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)

Chandler, Arizona, 85224, United States

Location

Arizona Clinical Trials ( Site 0158)

Flagstaff, Arizona, 86001, United States

Location

The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)

Peoria, Arizona, 85381, United States

Location

The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)

Tucson, Arizona, 85712, United States

Location

California Liver Research Institute ( Site 0113)

Pasadena, California, 91105, United States

Location

Acclaim Clinical Research ( Site 0137)

San Diego, California, 92120, United States

Location

Velocity Clinical Research, Panorama City ( Site 0124)

Van Nuys, California, 91405, United States

Location

Rocky Mountain Gastroenterology ( Site 0127)

Littleton, Colorado, 80120, United States

Location

Synergy Healthcare ( Site 0118)

Bradenton, Florida, 34209, United States

Location

Homestead Associates in Research, Inc. ( Site 0139)

Homestead, Florida, 33033, United States

Location

Florida Research Institute ( Site 0116)

Lakewood Rch, Florida, 34211, United States

Location

Floridian Clinical Research, LLC ( Site 0109)

Miami Lakes, Florida, 33016, United States

Location

Southeast Clinical Research Center ( Site 0119)

Dalton, Georgia, 30720, United States

Location

Delta Research Partners ( Site 0160)

Bastrop, Louisiana, 71220, United States

Location

Louisiana Research Center ( Site 0161)

Shreveport, Louisiana, 71105, United States

Location

Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)

Glen Burnie, Maryland, 21061, United States

Location

Velocity Clinical Research Rockville ( Site 0143)

Rockville, Maryland, 20854, United States

Location

Huron Gastroenterology ( Site 0102)

Ypsilanti, Michigan, 48197, United States

Location

The Machuca Foundation ( Site 0115)

Las Vegas, Nevada, 89101, United States

Location

Excel Clinical Research, LLC ( Site 0101)

Las Vegas, Nevada, 89109, United States

Location

Southwest Gastroenterology Associates ( Site 0129)

Albuquerque, New Mexico, 87109, United States

Location

Coastal Research Institute - Fayetteville ( Site 0159)

Fayetteville, North Carolina, 28304, United States

Location

Lucas Research, Inc ( Site 0105)

Morehead City, North Carolina, 28557, United States

Location

Texas Clinical Research Institute ( Site 0126)

Arlington, Texas, 76012, United States

Location

Pinnacle Clinical Research ( Site 0104)

Austin, Texas, 78757, United States

Location

Pinnacle Clinical Research-Corpus Christi ( Site 0156)

Corpus Christi, Texas, 78404, United States

Location

Zenos Clinical Research ( Site 0136)

Dallas, Texas, 75230, United States

Location

GI Alliance Department of Research ( Site 0162)

Fort Worth, Texas, 76104, United States

Location

Houston Research Institute ( Site 0172)

Houston, Texas, 77004, United States

Location

Houston Research Institute ( Site 0117)

Houston, Texas, 77079, United States

Location

American Research Corporation ( Site 0131)

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)

San Antonio, Texas, 78229, United States

Location

University of Virginia Health System ( Site 0164)

Charlottesville, Virginia, 22908, United States

Location

Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)

Adelaide, South Australia, 5042, Australia

Location

St Vincent's Hospital-Gastroenterology Department ( Site 1205)

Melbourne, Victoria, 3065, Australia

Location

Toronto General Hospital ( Site 0207)

Toronto, Ontario, M5G 2C4, Canada

Location

Diex Recherche Quebec ( Site 0204)

Québec, Quebec, G1V 4T3, Canada

Location

Fundacion Santa Fe de Bogota ( Site 0403)

Bogotá, Cundinamarca, 110111, Colombia

Location

Fundación Valle del Lili ( Site 0402)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704)

Nice, Alpes-Maritimes, 06202, France

Location

CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)

Pessac, Aquitaine, 33600, France

Location

Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)

Lyon, Auvergne-Rhône-Alpes, 69004, France

Location

Hôpital Beaujon-Hépatologie ( Site 0703)

Clichy, Hauts-de-Seine, 92110, France

Location

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)

Limoges, Limousin, 87042, France

Location

Rambam Health Care Campus ( Site 0801)

Haifa, 3109601, Israel

Location

Carmel Hospital-Liver Unit ( Site 0802)

Haifa, 3436212, Israel

Location

Shaare Zedek Medical Center ( Site 0805)

Jerusalem, 9103102, Israel

Location

Maccabi Health Services - Petah Tikva ( Site 0804)

Petah Tikva, 4925110, Israel

Location

Assuta Medical Center ( Site 0806)

Tel Aviv, 6789140, Israel

Location

Shinyurigaoka General Hospital ( Site 1401)

Kawasaki, Kanagawa, 215-0026, Japan

Location

Yokohama City University Hospital ( Site 1402)

Yokohama, Kanagawa, 236-0004, Japan

Location

University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)

Kyoto, 602-8566, Japan

Location

Osaka Metropolitan University Hospital ( Site 1403)

Osaka, 545-8586, Japan

Location

Saga University Hospital ( Site 1405)

Saga, 849-8501, Japan

Location

ISIS CLINICAL RESEARCH CENTER ( Site 0606)

Guaynabo, 00968, Puerto Rico

Location

Klinical Investigations Group-Clinical Research ( Site 0601)

San Juan, 00909, Puerto Rico

Location

Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)

Santander, Cantabria, 39005, Spain

Location

Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)

Valladolid, Castille and León, 47010, Spain

Location

Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)

Tomelloso, Ciudad Real, 13700, Spain

Location

CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)

A Coruña, La Coruna, 15006, Spain

Location

CHUS - Hospital Clinico Universitario ( Site 1011)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)

Madrid, 28046, Spain

Location

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)

Seville, 41013, Spain

Location

Chulalongkorn University ( Site 1301)

Bangkok, Bangkok, 10330, Thailand

Location

Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)

Bangkok, Bangkok, 10700, Thailand

Location

King's College Hospital ( Site 1104)

London, London, City of, SE5 9RL, United Kingdom

Location

Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): August 6, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (33); FR (5); IL (5); TH (2); AU (2); CA (2); ES (8); PR (2); GB (2); CO (2); JP (5)