A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
Launched by MERCK SHARP & DOHME LLC · Jun 13, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medicine called efinopegdutide to see if it can help people with a liver disease known as metabolic dysfunction-associated steatohepatitis (MASH), which is caused by having too much fat in the liver. The researchers want to find out if this medicine can reduce fat, inflammation, and scarring in the liver, as well as learn more about how safe it is and how well people can tolerate it.
To participate in this study, individuals need to have compensated cirrhosis from MASH and either have type 2 diabetes that is managed by diet or medication, or not have diabetes at all. The study is currently looking for participants aged 65 to 75. Those with other liver diseases or certain serious health conditions may not be eligible. If you join the trial, you can expect to receive the study medicine and attend regular check-ups to monitor your health. This research is important as it could lead to new treatments for people with this liver condition.
Gender
ALL
Eligibility criteria
- 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
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bradenton, Florida, United States
Miami Lakes, Florida, United States
San Juan, , Puerto Rico
Las Vegas, Nevada, United States
Arlington, Texas, United States
Dallas, Texas, United States
Haifa, , Israel
Jerusalem, , Israel
Kawasaki, Kanagawa, Japan
Osaka, , Japan
Chandler, Arizona, United States
San Diego, California, United States
Homestead, Florida, United States
Lakewood Ranch, Florida, United States
Miami Lakes, Florida, United States
Rockville, Maryland, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Melbourne, Victoria, Australia
Yokohama, Kanagawa, Japan
Guaynabo, , Puerto Rico
Barcelona, , Spain
Madrid, , Spain
Flagstaff, Arizona, United States
Peoria, Arizona, United States
Tucson, Arizona, United States
Bastrop, Louisiana, United States
Glen Burnie, Maryland, United States
Morehead City, North Carolina, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Adelaide, South Australia, Australia
Kyoto, , Japan
Saga, , Japan
Santander, Cantabria, Spain
Valladolid, Castilla Y Leon, Spain
London, London, City Of, United Kingdom
Pasadena, California, United States
Van Nuys, California, United States
Dalton, Georgia, United States
Albuquerque, New Mexico, United States
Fayetteville, North Carolina, United States
Pessac, Aquitaine, France
Lyon, Rhone Alpes, France
Haifa, , Israel
Bangkok, Krung Thep Maha Nakhon, Thailand
Bangkok, Krung Thep Maha Nakhon, Thailand
Littleton, Colorado, United States
Shreveport, Louisiana, United States
Ypsilanti, Michigan, United States
Fort Worth, Texas, United States
Quebec, , Canada
Cali, Valle Del Cauca, Colombia
Limoges, Limousin, France
Tomelloso, Ciudad Real, Spain
A Coruña, La Coruna, Spain
Sevilla, , Spain
Aberdeen, Scotland, United Kingdom
Bradenton, Florida, United States
Quebec, , Canada
Bogotá, Cundinamarca, Colombia
Petah Tikva, , Israel
Las Vegas, Nevada, United States
Toronto, Ontario, Canada
Houston, Texas, United States
Chandler, Arizona, United States
Limoges, Limousin, France
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported