ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-07-12
Study Completion:2026-09-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06465186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
  2. * Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes
  1. * Has history of a liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
  2. * Has history of type 1 diabetes
  3. * Had a bariatric surgical procedure less than 5 years before entry into the study
  4. * History of pancreatitis
  5. * 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

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
Chandler, Arizona, 85224
United States
Arizona Clinical Trials ( Site 0158)
Flagstaff, Arizona, 86001
United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
Peoria, Arizona, 85381
United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
Tucson, Arizona, 85712
United States
California Liver Research Institute ( Site 0113)
Pasadena, California, 91105
United States
Acclaim Clinical Research ( Site 0137)
San Diego, California, 92120
United States
Velocity Clinical Research, Panorama City ( Site 0124)
Van Nuys, California, 91405
United States
Rocky Mountain Gastroenterology ( Site 0127)
Littleton, Colorado, 80120
United States
Synergy Healthcare ( Site 0118)
Bradenton, Florida, 34209
United States
Homestead Associates in Research, Inc. ( Site 0139)
Homestead, Florida, 33033
United States
Florida Research Institute ( Site 0116)
Lakewood Rch, Florida, 34211
United States
Floridian Clinical Research, LLC ( Site 0109)
Miami Lakes, Florida, 33016
United States
Southeast Clinical Research Center ( Site 0119)
Dalton, Georgia, 30720
United States
Delta Research Partners ( Site 0160)
Bastrop, Louisiana, 71220
United States
Louisiana Research Center ( Site 0161)
Shreveport, Louisiana, 71105
United States
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
Glen Burnie, Maryland, 21061
United States
Velocity Clinical Research Rockville ( Site 0143)
Rockville, Maryland, 20854
United States
Huron Gastroenterology ( Site 0102)
Ypsilanti, Michigan, 48197
United States
The Machuca Foundation ( Site 0115)
Las Vegas, Nevada, 89101
United States
Excel Clinical Research, LLC ( Site 0101)
Las Vegas, Nevada, 89109
United States
Southwest Gastroenterology Associates ( Site 0129)
Albuquerque, New Mexico, 87109
United States
Coastal Research Institute - Fayetteville ( Site 0159)
Fayetteville, North Carolina, 28304
United States
Lucas Research, Inc ( Site 0105)
Morehead City, North Carolina, 28557
United States
Texas Clinical Research Institute ( Site 0126)
Arlington, Texas, 76012
United States
Pinnacle Clinical Research ( Site 0104)
Austin, Texas, 78757
United States
Pinnacle Clinical Research-Corpus Christi ( Site 0156)
Corpus Christi, Texas, 78404
United States
Zenos Clinical Research ( Site 0136)
Dallas, Texas, 75230
United States
GI Alliance Department of Research ( Site 0162)
Fort Worth, Texas, 76104
United States
Houston Research Institute ( Site 0172)
Houston, Texas, 77030
United States
Houston Research Institute ( Site 0117)
Houston, Texas, 77079
United States
American Research Corporation ( Site 0131)
San Antonio, Texas, 78215
United States
Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
San Antonio, Texas, 78229
United States
University of Virginia Health System ( Site 0164)
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12
Study Completion Date2026-09-21

Study Record Updates

Study Start Date2024-07-12
Study Completion Date2026-09-21

Terms related to this study

Additional Relevant MeSH Terms

  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
  • NAFLD
  • Metabolic Dysfunction-associated Steatotic Liver Disease
  • Metabolic Dysfunction-associated Steatohepatitis