Treatment of liver disease with efinopegdutide
Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis
This study is testing if efinopegdutide can help people with liver disease caused by fat buildup in the liver feel better by reducing liver fat, inflammation, and scarring.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 62 sites (Chandler, Arizona and 61 other locations) |
| Trial ID | NCT06465186 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness of efinopegdutide in treating compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH). The study aims to determine if the medication can reduce liver fat, inflammation, and fibrosis while also assessing its safety and tolerability among participants. Patients will be randomly assigned to receive either efinopegdutide or a placebo to evaluate the drug's impact on their liver condition.
Who should consider this trial
Good fit: Ideal candidates include individuals with compensated cirrhosis due to MASH, who may also have controlled type 2 diabetes.
Not a fit: Patients with other liver diseases or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver health and quality of life for patients with MASH.
How similar studies have performed: While there have been studies on similar conditions, the specific approach with efinopegdutide is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandler, Arizona and 61 other locations
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149) — Chandler, Arizona, United States (Recruiting)
- Arizona Clinical Trials ( Site 0158) — Flagstaff, Arizona, United States (Recruiting)
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120) — Peoria, Arizona, United States (Recruiting)
- The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111) — Tucson, Arizona, United States (Recruiting)
- California Liver Research Institute ( Site 0113) — Pasadena, California, United States (Recruiting)
- Acclaim Clinical Research ( Site 0137) — San Diego, California, United States (Recruiting)
- Velocity Clinical Research, Panorama City ( Site 0124) — Van Nuys, California, United States (Recruiting)
- Rocky Mountain Gastroenterology ( Site 0127) — Littleton, Colorado, United States (Recruiting)
- Synergy Healthcare ( Site 0118) — Bradenton, Florida, United States (Recruiting)
- Homestead Associates in Research, Inc. ( Site 0139) — Homestead, Florida, United States (Recruiting)
- Florida Research Institute ( Site 0116) — Lakewood Ranch, Florida, United States (Recruiting)
- Floridian Clinical Research, LLC ( Site 0109) — Miami Lakes, Florida, United States (Recruiting)
- Southeast Clinical Research Center ( Site 0119) — Dalton, Georgia, United States (Recruiting)
- Delta Research Partners ( Site 0160) — Bastrop, Louisiana, United States (Recruiting)
- Louisiana Research Center ( Site 0161) — Shreveport, Louisiana, United States (Recruiting)
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130) — Glen Burnie, Maryland, United States (Recruiting)
- Velocity Clinical Research Rockville ( Site 0143) — Rockville, Maryland, United States (Recruiting)
- Huron Gastroenterology ( Site 0102) — Ypsilanti, Michigan, United States (Recruiting)
- The Machuca Foundation ( Site 0115) — Las Vegas, Nevada, United States (Recruiting)
- Excel Clinical Research, LLC ( Site 0101) — Las Vegas, Nevada, United States (Recruiting)
- Southwest Gastroenterology Associates ( Site 0129) — Albuquerque, New Mexico, United States (Recruiting)
- Coastal Research Institute - Fayetteville ( Site 0159) — Fayetteville, North Carolina, United States (Recruiting)
- Lucas Research, Inc ( Site 0105) — Morehead City, North Carolina, United States (Recruiting)
- Texas Clinical Research Institute ( Site 0126) — Arlington, Texas, United States (Recruiting)
- Pinnacle Clinical Research ( Site 0104) — Austin, Texas, United States (Recruiting)
- Pinnacle Clinical Research-Corpus Christi ( Site 0156) — Corpus Christi, Texas, United States (Recruiting)
- Zenos Clinical Research ( Site 0136) — Dallas, Texas, United States (Recruiting)
- GI Alliance Department of Research ( Site 0162) — Fort Worth, Texas, United States (Recruiting)
- Houston Research Institute ( Site 0117) — Houston, Texas, United States (Recruiting)
- American Research Corporation ( Site 0131) — San Antonio, Texas, United States (Recruiting)
- Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125) — San Antonio, Texas, United States (Recruiting)
- Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202) — Adelaide, South Australia, Australia (Recruiting)
- St Vincent's Hospital-Gastroenterology Department ( Site 1205) — Melbourne, Victoria, Australia (Recruiting)
- Toronto General Hospital ( Site 0207) — Toronto, Ontario, Canada (Recruiting)
- Diex Recherche Quebec ( Site 0204) — Quebec, Canada (Recruiting)
- Fundacion Santa Fe de Bogota ( Site 0403) — Bogotá, Cundinamarca, Colombia (Recruiting)
- Fundación Valle del Lili ( Site 0402) — Cali, Valle Del Cauca, Colombia (Recruiting)
- CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701) — Pessac, Aquitaine, France (Recruiting)
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702) — Limoges, Limousin, France (Recruiting)
- Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705) — Lyon, Rhone-Alpes, France (Recruiting)
- Rambam Health Care Campus ( Site 0801) — Haifa, Israel (Recruiting)
- Carmel Hospital-Liver Unit ( Site 0802) — Haifa, Israel (Recruiting)
- Shaare Zedek Medical Center ( Site 0805) — Jerusalem, Israel (Recruiting)
- Maccabi Health Services - Petah Tikva ( Site 0804) — Petah Tikva, Israel (Recruiting)
- Shinyurigaoka General Hospital ( Site 1401) — Kawasaki, Kanagawa, Japan (Recruiting)
- Yokohama City University Hospital ( Site 1402) — Yokohama, Kanagawa, Japan (Recruiting)
- University Hospital,Kyoto Prefectural University of Medicine ( Site 1404) — Kyoto, Japan (Recruiting)
- Osaka Metropolitan University Hospital ( Site 1403) — Osaka, Japan (Recruiting)
- Saga University Hospital ( Site 1405) — Saga, Japan (Recruiting)
- ISIS CLINICAL RESEARCH CENTER ( Site 0606) — Guaynabo, Puerto Rico (Recruiting)
+12 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.