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Активно (без набиране) Фаза 2 NCT06465186

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis NAFLD Metabolic Dysfunction-associated Steatotic Liver Disease Metabolic Dysfunction-associated Steatohepatitis

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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
Кой може да участва
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
Места на провеждане 11
Австралия (1)
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
Adelaide , South Australia
Канада (1)
Toronto General Hospital ( Site 0207)
Toronto , Ontario
Colombia (1)
Fundacion Santa Fe de Bogota ( Site 0403)
Bogotá , Cundinamarca
Франция (1)
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704)
Nice , Alpes-Maritimes
Израел (1)
Rambam Health Care Campus ( Site 0801)
Haifa
Япония (1)
Shinyurigaoka General Hospital ( Site 1401)
Kawasaki , Kanagawa
Puerto Rico (1)
ISIS CLINICAL RESEARCH CENTER ( Site 0606)
Guaynabo
Испания (1)
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
Santander , Cantabria
Тайланд (1)
Chulalongkorn University ( Site 1301)
Bangkok , Bangkok
Великобритания (1)
King's College Hospital ( Site 1104)
London , London, City of
САЩ (1)
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
Chandler , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
12.07.2024
Крайна дата
06.08.2026
Регистрационен номер
NCT06465186
Източник
anzctr
Запитване за медицински туризъм

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