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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Efinopegdutide 		Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks.
  • Combination Product: Efinopegdutide
    Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
    Other names:
    • MK-6024
Placebo Comparator
Placebo 		Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine. Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks.
  • Combination Product: Placebo
    Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.

Recruiting Locations

The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
Chandler, Arizona 85224
Contact:
Study Coordinator
888-577-8839

Arizona Clinical Trials ( Site 0158)
Flagstaff, Arizona 86001
Contact:
Study Coordinator
480-470-4000

The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
Peoria, Arizona 85381
Contact:
Study Coordinator
480-470-4000

The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
Tucson, Arizona 85712
Contact:
Study Coordinator
520-485-2000

California Liver Research Institute ( Site 0113)
Pasadena, California 91105
Contact:
Study Coordinator
626-795-5769

Acclaim Clinical Research ( Site 0137)
San Diego, California 92120
Contact:
Study Coordinator
858-299-0009

Velocity Clinical Research, Panorama City ( Site 0124)
Van Nuys, California 91405
Contact:
Study Coordinator
818-532-6880

Rocky Mountain Gastroenterology ( Site 0127)
Littleton, Colorado 80120
Contact:
Study Coordinator
303-288-8616

Synergy Healthcare ( Site 0118)
Bradenton, Florida 34209
Contact:
Study Coordinator
941-780-1415

Homestead Associates in Research, Inc. ( Site 0139)
Homestead, Florida 33033
Contact:
Study Coordinator
305-246-0873

Florida Research Institute ( Site 0116)
Lakewood Ranch, Florida 34211
Contact:
Study Coordinator
888-577-8839

Floridian Clinical Research, LLC ( Site 0109)
Miami Lakes, Florida 33016
Contact:
Study Coordinator
305-587-9977

Southeast Clinical Research Center ( Site 0119)
Dalton, Georgia 30720
Contact:
Study Coordinator
706-913-1779

Delta Research Partners ( Site 0160)
Bastrop, Louisiana 71220
Contact:
Study Coordinator
318-283-3600

Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
Glen Burnie, Maryland 21061
Contact:
Study Coordinator
410-783-8441

Velocity Clinical Research Rockville ( Site 0143)
Rockville, Maryland 20854
Contact:
Study Coordinator
240-698-2800

Huron Gastroenterology ( Site 0102)
Ypsilanti, Michigan 48197
Contact:
Study Coordinator
724-418-7736

The Machuca Foundation ( Site 0115)
Las Vegas, Nevada 89101
Contact:
Study Coordinator
725-400-2550

Excel Clinical Research, LLC ( Site 0101)
Las Vegas, Nevada 89109
Contact:
Study Coordinator
702-680-1500

Southwest Gastroenterology Associates ( Site 0129)
Albuquerque, New Mexico 87109
Contact:
Study Coordinator
505-999-1600

Coastal Research Institute - Fayetteville ( Site 0159)
Fayetteville, North Carolina 28304
Contact:
Study Coordinator
910-500-3146

Lucas Research, Inc ( Site 0105)
Morehead City, North Carolina 28557
Contact:
Study Coordinator
252-222-5700 x106

Texas Clinical Research Institute ( Site 0126)
Arlington, Texas 76012
Contact:
Study Coordinator
512-384-1560

Pinnacle Clinical Research ( Site 0104)
Austin, Texas 78757
Contact:
Study Coordinator
512-384-1560

Pinnacle Clinical Research-Corpus Christi ( Site 0156)
Corpus Christi, Texas 78404
Contact:
Study Coordinator
361-400-5352

Zenos Clinical Research ( Site 0136)
Dallas, Texas 75230
Contact:
Study Coordinator
469-402-4163

GI Alliance Department of Research ( Site 0162)
Fort Worth, Texas 76104
Contact:
Study Coordinator
817-310-4478

Houston Research Institute ( Site 0117)
Houston, Texas 77079
Contact:
Study Coordinator
281-809-3234

American Research Corporation ( Site 0131)
San Antonio, Texas 78215
Contact:
Study Coordinator
210-253-3426

Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
San Antonio, Texas 78229
Contact:
Study Coordinator
210-982-0320

ISIS CLINICAL RESEARCH CENTER ( Site 0606)
Guaynabo, Puerto Rico 00968
Contact:
Study Coordinator
+9393630841

Klinical Investigations Group-Clinical Research ( Site 0601)
San Juan, Puerto Rico 00909
Contact:
Study Coordinator
7879197865

More Details

NCT ID
NCT06465186
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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