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
Who can participate
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
Locations
11
Australia (1)
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
Adelaide , South Australia
Canada (1)
Toronto General Hospital ( Site 0207)
Toronto , Ontario
Colombia (1)
Fundacion Santa Fe de Bogota ( Site 0403)
Bogotá , Cundinamarca
France (1)
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704)
Nice , Alpes-Maritimes
Israel (1)
Rambam Health Care Campus ( Site 0801)
Haifa
Japan (1)
Shinyurigaoka General Hospital ( Site 1401)
Kawasaki , Kanagawa
Puerto Rico (1)
ISIS CLINICAL RESEARCH CENTER ( Site 0606)
Guaynabo
Spain (1)
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
Santander , Cantabria
Thailand (1)
Chulalongkorn University ( Site 1301)
Bangkok , Bangkok
United Kingdom (1)
King's College Hospital ( Site 1104)
London , London, City of
United States (1)
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)