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Active (not recruiting) Phase 2 NCT06465186

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

Phase 2 – studying effectiveness and dosage
Conditions: Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis NAFLD Metabolic Dysfunction-associated Steatotic Liver Disease Metabolic Dysfunction-associated Steatohepatitis

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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)
Chandler , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
12.07.2024
Completion date
06.08.2026
Registry ID
NCT06465186
Source
anzctr
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