A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
- Conditions
- NAFLDMetabolic Dysfunction-associated Steatotic Liver DiseaseNon-alcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisMetabolic Dysfunction-associated Steatohepatitis
- Interventions
- Combination Product: EfinopegdutideCombination Product: Placebo
- Registration Number
- NCT06465186
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Efinopegdutide 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. Placebo 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Liver Fat Content (LFC) at Week 28 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 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) Up to approximately 36 weeks An AE is a health problem that happens or worsens during the study
- Secondary Outcome Measures
Name Time Method Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28 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.Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28 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.Percent Change from Baseline in Body Weight at Week 28 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
Change from Baseline in Iron-corrected T1 (cT1) at Week 28 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.Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28 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.Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28 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.
Trial Locations
- Locations (62)
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
🇺🇸Chandler, Arizona, United States
Arizona Clinical Trials ( Site 0158)
🇺🇸Flagstaff, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
🇺🇸Peoria, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
🇺🇸Tucson, Arizona, United States
California Liver Research Institute ( Site 0113)
🇺🇸Pasadena, California, United States
Acclaim Clinical Research ( Site 0137)
🇺🇸San Diego, California, United States
Velocity Clinical Research, Panorama City ( Site 0124)
🇺🇸Van Nuys, California, United States
Rocky Mountain Gastroenterology ( Site 0127)
🇺🇸Littleton, Colorado, United States
Synergy Healthcare ( Site 0118)
🇺🇸Bradenton, Florida, United States
Homestead Associates in Research, Inc. ( Site 0139)
🇺🇸Homestead, Florida, United States
Florida Research Institute ( Site 0116)
🇺🇸Lakewood Ranch, Florida, United States
Floridian Clinical Research, LLC ( Site 0109)
🇺🇸Miami Lakes, Florida, United States
Southeast Clinical Research Center ( Site 0119)
🇺🇸Dalton, Georgia, United States
Delta Research Partners ( Site 0160)
🇺🇸Bastrop, Louisiana, United States
Louisiana Research Center ( Site 0161)
🇺🇸Shreveport, Louisiana, United States
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
🇺🇸Glen Burnie, Maryland, United States
Velocity Clinical Research Rockville ( Site 0143)
🇺🇸Rockville, Maryland, United States
Huron Gastroenterology ( Site 0102)
🇺🇸Ypsilanti, Michigan, United States
The Machuca Foundation ( Site 0115)
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research, LLC ( Site 0101)
🇺🇸Las Vegas, Nevada, United States
Southwest Gastroenterology Associates ( Site 0129)
🇺🇸Albuquerque, New Mexico, United States
Coastal Research Institute - Fayetteville ( Site 0159)
🇺🇸Fayetteville, North Carolina, United States
Lucas Research, Inc ( Site 0105)
🇺🇸Morehead City, North Carolina, United States
Texas Clinical Research Institute ( Site 0126)
🇺🇸Arlington, Texas, United States
Pinnacle Clinical Research ( Site 0104)
🇺🇸Austin, Texas, United States
Pinnacle Clinical Research-Corpus Christi ( Site 0156)
🇺🇸Corpus Christi, Texas, United States
Zenos Clinical Research ( Site 0136)
🇺🇸Dallas, Texas, United States
GI Alliance Department of Research ( Site 0162)
🇺🇸Fort Worth, Texas, United States
Houston Research Institute ( Site 0117)
🇺🇸Houston, Texas, United States
American Research Corporation ( Site 0131)
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
🇺🇸San Antonio, Texas, United States
Toronto General Hospital ( Site 0207)
🇨🇦Toronto, Ontario, Canada
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
🇦🇺Adelaide, South Australia, Australia
St Vincent's Hospital-Gastroenterology Department ( Site 1205)
🇦🇺Melbourne, Victoria, Australia
Diex Recherche Quebec ( Site 0204)
🇨🇦Quebec, Canada
Fundacion Santa Fe de Bogota ( Site 0403)
🇨🇴Bogotá, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0402)
🇨🇴Cali, Valle Del Cauca, Colombia
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)
🇫🇷Pessac, Aquitaine, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
🇫🇷Limoges, Limousin, France
Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)
🇫🇷Lyon, Rhone-Alpes, France
Rambam Health Care Campus ( Site 0801)
🇮🇱Haifa, Israel
Carmel Hospital-Liver Unit ( Site 0802)
🇮🇱Haifa, Israel
Shaare Zedek Medical Center ( Site 0805)
🇮🇱Jerusalem, Israel
Maccabi Health Services - Petah Tikva ( Site 0804)
🇮🇱Petah Tikva, Israel
Shinyurigaoka General Hospital ( Site 1401)
🇯🇵Kawasaki, Kanagawa, Japan
Yokohama City University Hospital ( Site 1402)
🇯🇵Yokohama, Kanagawa, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
🇯🇵Kyoto, Japan
Osaka Metropolitan University Hospital ( Site 1403)
🇯🇵Osaka, Japan
Saga University Hospital ( Site 1405)
🇯🇵Saga, Japan
ISIS CLINICAL RESEARCH CENTER ( Site 0606)
🇵🇷Guaynabo, Puerto Rico
Klinical Investigations Group-Clinical Research ( Site 0601)
🇵🇷San Juan, Puerto Rico
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
🇪🇸Santander, Cantabria, Spain
Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)
🇪🇸Valladolid, Castilla Y Leon, Spain
Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
🇪🇸Tomelloso, Ciudad Real, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
🇪🇸A Coruña, La Coruna, Spain
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
🇪🇸Barcelona, Spain
Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
🇪🇸Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)
🇪🇸Sevilla, Spain
Chulalongkorn University ( Site 1301)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
King's College Hospital ( Site 1104)
🇬🇧London, London, City Of, United Kingdom
Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
🇬🇧Aberdeen, Scotland, United Kingdom