Non-alcoholic Fatty Liver DiseasePhase 2NCT06465186
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
A Phase 2 study testing Efinopegdutide in people with Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Merck Sharp & Dohme LLC at 68 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD
- What is being tested?
- Efinopegdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 68 sitesin 11 countries
- Study dates
- 12 Jul 2024to 3 Aug 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
68 sites in 11 countries.
68 sites in 11 countries
United States33 sites
Southwest Gastroenterology Associates ( Site 0129)
Albuquerque, New Mexico, 87109
Texas Clinical Research Institute ( Site 0126)
Arlington, Texas, 76012
Pinnacle Clinical Research ( Site 0104)
Austin, Texas, 78757
Delta Research Partners ( Site 0160)
Bastrop, Louisiana, 71220
Synergy Healthcare ( Site 0118)
Bradenton, Florida, 34209
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
Chandler, Arizona, 85224
University of Virginia Health System ( Site 0164)
Charlottesville, Virginia, 22908
Pinnacle Clinical Research-Corpus Christi ( Site 0156)
Corpus Christi, Texas, 78404
Zenos Clinical Research ( Site 0136)
Dallas, Texas, 75230
Southeast Clinical Research Center ( Site 0119)
Dalton, Georgia, 30720
Coastal Research Institute - Fayetteville ( Site 0159)
Fayetteville, North Carolina, 28304
Arizona Clinical Trials ( Site 0158)
Flagstaff, Arizona, 86001
GI Alliance Department of Research ( Site 0162)
Fort Worth, Texas, 76104
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
Glen Burnie, Maryland, 21061
Homestead Associates in Research, Inc. ( Site 0139)
Homestead, Florida, 33033
Houston Research Institute ( Site 0172)
Houston, Texas, 77004
Houston Research Institute ( Site 0117)
Houston, Texas, 77079
Florida Research Institute ( Site 0116)
Lakewood Rch, Florida, 34211
The Machuca Foundation ( Site 0115)
Las Vegas, Nevada, 89101
Excel Clinical Research, LLC ( Site 0101)
Las Vegas, Nevada, 89109
Rocky Mountain Gastroenterology ( Site 0127)
Littleton, Colorado, 80120
Floridian Clinical Research, LLC ( Site 0109)
Miami Lakes, Florida, 33016
Lucas Research, Inc ( Site 0105)
Morehead City, North Carolina, 28557
California Liver Research Institute ( Site 0113)
Pasadena, California, 91105
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
Peoria, Arizona, 85381
Velocity Clinical Research Rockville ( Site 0143)
Rockville, Maryland, 20854
American Research Corporation ( Site 0131)
San Antonio, Texas, 78215
Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
San Antonio, Texas, 78229
Acclaim Clinical Research ( Site 0137)
San Diego, California, 92120
Louisiana Research Center ( Site 0161)
Shreveport, Louisiana, 71105
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
Tucson, Arizona, 85712
Velocity Clinical Research, Panorama City ( Site 0124)
Van Nuys, California, 91405
Huron Gastroenterology ( Site 0102)
Ypsilanti, Michigan, 48197
Spain8 sites
CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
A Coruña, La Coruna, 15006
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
Barcelona, 08035
Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
Madrid, 28046
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
Santander, Cantabria, 39005
CHUS - Hospital Clinico Universitario ( Site 1011)
Santiago de Compostela, La Coruna, 15706
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)
Seville, 41013
Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
Tomelloso, Ciudad Real, 13700
Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)
Valladolid, Castille and León, 47010
France5 sites
Hôpital Beaujon-Hépatologie ( Site 0703)
Clichy, Hauts-de-Seine, 92110
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
Limoges, Limousin, 87042
Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)
Lyon, Auvergne-Rhône-Alpes, 69004
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704)
Nice, Alpes-Maritimes, 06202
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)
Pessac, Aquitaine, 33600
Israel5 sites
Rambam Health Care Campus ( Site 0801)
Haifa, 3109601
Carmel Hospital-Liver Unit ( Site 0802)
Haifa, 3436212
Shaare Zedek Medical Center ( Site 0805)
Jerusalem, 9103102
Maccabi Health Services - Petah Tikva ( Site 0804)
Petah Tikva, 4925110
Assuta Medical Center ( Site 0806)
Tel Aviv, 6789140
Japan5 sites
Shinyurigaoka General Hospital ( Site 1401)
Kawasaki, Kanagawa, 215-0026
University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
Kyoto, 602-8566
Osaka Metropolitan University Hospital ( Site 1403)
Osaka, 545-8586
Saga University Hospital ( Site 1405)
Saga, 849-8501
Yokohama City University Hospital ( Site 1402)
Yokohama, Kanagawa, 236-0004
Australia2 sites
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
Adelaide, South Australia, 5042
St Vincent's Hospital-Gastroenterology Department ( Site 1205)
Melbourne, Victoria, 3065
Canada2 sites
Diex Recherche Quebec ( Site 0204)
Québec, Quebec, G1V 4T3
Toronto General Hospital ( Site 0207)
Toronto, Ontario, M5G 2C4
Colombia2 sites
Fundacion Santa Fe de Bogota ( Site 0403)
Bogotá, Cundinamarca, 110111
Fundación Valle del Lili ( Site 0402)
Cali, Valle del Cauca Department, 760032
Puerto Rico2 sites
ISIS CLINICAL RESEARCH CENTER ( Site 0606)
Guaynabo, 00968
Klinical Investigations Group-Clinical Research ( Site 0601)
San Juan, 00909
Thailand2 sites
Chulalongkorn University ( Site 1301)
Bangkok, Bangkok, 10330
Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
Bangkok, Bangkok, 10700
United Kingdom2 sites
Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
Aberdeen, Scotland, AB25 2ZN
King's College Hospital ( Site 1104)
London, London, City of, SE5 9RL
About this study
Official title: 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
- Conditions
- Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD, Metabolic Dysfunction-associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis
- Being tested
- Efinopegdutide, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfinopegdutideCombination product
Also called MK-6024
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
PlaceboCombination product
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Up to approximately 28 weeks
Secondary outcomes (6)
Change from Baseline in Iron-corrected T1 (cT1) at Week 28
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.
Measured: Baseline and up to 28 Weeks
Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28
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.
Measured: Baseline and up to 28 weeks
Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28
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.
Measured: Baseline and up to 28 weeks
Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28
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.
Measured: Baseline and up to 28 weeks
Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28
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.
Measured: Baseline and up to 28 weeks
Percent Change from Baseline in Body Weight at Week 28
Body weight will be measured using a standardized, digital scale. The percent change from baseline in body weight after 28 weeks will be reported
Measured: Baseline and up to approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start12 Jul 2024
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465186
- Sponsor's protocol ID
- 6024-017
- Other IDs
- 2024-510923-20-00, MK-6024-017, jRCT2031240217, U1111-1302-7589
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf