A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD, Metabolic Dysfunction-associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis
In brief
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
Key facts
- Study ID
- NCT06465186
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 80
- Starts
- 2024-07-12
- Expected to finish
- 2026-08-06
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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 Rch, 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
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149) — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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