Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
NCT ID: NCT06482112
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2024-07-29
2025-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Efinopegdutide Q1W 10 mg
Participants will receive efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.
Efinopegdutide
SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm
Efinopegdutide Q2W 10 mg
Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.
Efinopegdutide
SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm
Efinopegdutide Q2W 15 mg
Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Efinopegdutide
SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm
Interventions
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Efinopegdutide
SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has no history of type 2 diabetes mellitus (T2DM) OR has a history of T2DM with a glycated hemoglobin (A1C) ≤9% AND the T2DM is controlled by diet or stable doses of oral antihyperglycemic agents (AHAs)
Exclusion Criteria
* Has evidence of decompensated liver disease including, but not limited to ascites, esophageal or gastric variceal bleeding, hepatocellular carcinoma, hepatic encephalopathy, splenomegaly, or spontaneous bacterial peritonitis
* Has a history of pancreatitis
* Has a history of type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy.
* Has symptomatic hyperglycemia
* Has a history of a bariatric surgical procedure ≤5 years before Screening or a known clinically significant gastric emptying abnormality
* Has a history of obesity with a known secondary cause
* Has significant systemic or major illnesses, including recent (≤6 months before Screening) onset of events of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
* Is unable to have Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) due to: Claustrophobia to a degree that prevents tolerance of an MRI-PDFF scanning procedure. Note: Sedation is permitted, at the discretion of the investigator; Metallic implants that prevent MRI-PDFF examination; Exceeds the body habitus and/or weight limitations for the MRI scanner
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp and Dohme LLC
Locations
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The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0
Chandler, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)
Peoria, Arizona, United States
Arizona Liver Health ( Site 0211)
Tucson, Arizona, United States
Del Sol Research Management, LLC ( Site 0209)
Tucson, Arizona, United States
Om Research LLC ( Site 0207)
Camarillo, California, United States
Gastroenterology and Liver Institute ( Site 0263)
Escondido, California, United States
Velocity Clinical Research, Gardena ( Site 0235)
Gardena, California, United States
Velocity Clinical Research, Huntington Park ( Site 0210)
Huntington Park, California, United States
California Liver Research Institute ( Site 0216)
Pasadena, California, United States
Acclaim Clinical Research ( Site 0241)
San Diego, California, United States
Velocity Clinical Research, Santa Ana ( Site 0250)
Santa Ana, California, United States
Velocity Clinical Research, Panorama City ( Site 0228)
Van Nuys, California, United States
Excel Medical Clinical Trials ( Site 0268)
Boca Raton, Florida, United States
AGA Clinical Trials ( Site 0274)
Hialeah, Florida, United States
Neoclinical Research ( Site 0275)
Hialeah, Florida, United States
Homestead Associates in Research, Inc. ( Site 0243)
Homestead, Florida, United States
Floridian Clinical Research, LLC ( Site 0208)
Miami Lakes, Florida, United States
Southeast Clinical Research Center ( Site 0223)
Dalton, Georgia, United States
Velocity Clinical Research Rockville ( Site 0245)
Rockville, Maryland, United States
The Machuca Foundation ( Site 0218)
Las Vegas, Nevada, United States
Excel Clinical Research, LLC ( Site 0200)
Las Vegas, Nevada, United States
Basil Clinical ( Site 0246)
Inwood, New York, United States
Lucas Research, Inc ( Site 0204)
Morehead City, North Carolina, United States
Texas Clinical Research Institute ( Site 0230)
Arlington, Texas, United States
Pinnacle Clinical Research ( Site 0203)
Austin, Texas, United States
Velocity Clinical Research, Austin ( Site 0201)
Austin, Texas, United States
Pinnacle Clinical Research-Corpus Christi ( Site 0267)
Corpus Christi, Texas, United States
Zenos Clinical Research ( Site 0240)
Dallas, Texas, United States
South Texas Research Institute ( Site 0226)
Edinburg, Texas, United States
Houston Research Institute ( Site 0221)
Houston, Texas, United States
American Research Corporation ( Site 0234)
San Antonio, Texas, United States
Clinical Trials of Texas, LLC-Clinical Research ( Site 0252)
San Antonio, Texas, United States
Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229)
San Antonio, Texas, United States
Impact Research Institute ( Site 0227)
Waco, Texas, United States
Olympus Family Medicine/CCT Research ( Site 0266)
Holladay, Utah, United States
South Ogden Family Medicine/ CCT Research ( Site 0255)
South Ogden, Utah, United States
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104)
Caguas, , Puerto Rico
Klinical Investigations Group-Clinical Research ( Site 0100)
San Juan, , Puerto Rico
Pan American Center for Oncology Trials - Ciudadela ( Site 0101)
San Juan, , Puerto Rico
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-6024-016
Identifier Type: OTHER
Identifier Source: secondary_id
6024-016
Identifier Type: -
Identifier Source: org_study_id
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