Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)

May 5, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 2a Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of Efinopegdutide (MK-6024) in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease

This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104)
      • San Juan, Puerto Rico, 00909
        • Klinical Investigations Group-Clinical Research ( Site 0100)
      • San Juan, Puerto Rico, 00909
        • Pan American Center for Oncology Trials - Ciudadela ( Site 0101)
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0
      • Peoria, Arizona, United States, 85381
        • The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)
      • Tucson, Arizona, United States, 85712
        • Arizona Liver Health ( Site 0211)
      • Tucson, Arizona, United States, 85715
        • Del Sol Research Management, LLC ( Site 0209)
    • California
      • Camarillo, California, United States, 93012
        • Om Research LLC ( Site 0207)
      • Escondido, California, United States, 92025
        • Gastroenterology and Liver Institute ( Site 0263)
      • Gardena, California, United States, 90247
        • Velocity Clinical Research, Gardena ( Site 0235)
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research, Huntington Park ( Site 0210)
      • Pasadena, California, United States, 91105
        • California Liver Research Institute ( Site 0216)
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research ( Site 0241)
      • Santa Ana, California, United States, 92704
        • Velocity Clinical Research, Santa Ana ( Site 0250)
      • Van Nuys, California, United States, 91405
        • Velocity Clinical Research, Panorama City ( Site 0228)
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials ( Site 0268)
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials ( Site 0274)
      • Hialeah, Florida, United States, 33016
        • Neoclinical Research ( Site 0275)
      • Homestead, Florida, United States, 33033
        • Homestead Associates in Research, Inc. ( Site 0243)
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research, LLC ( Site 0208)
    • Georgia
      • Dalton, Georgia, United States, 30720
        • Southeast Clinical Research Center ( Site 0223)
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research Rockville ( Site 0245)
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • The Machuca Foundation ( Site 0218)
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research, LLC ( Site 0200)
    • New York
      • Inwood, New York, United States, 11096
        • Basil Clinical ( Site 0246)
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research, Inc ( Site 0204)
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute ( Site 0230)
      • Austin, Texas, United States, 78757
        • Pinnacle Clinical Research ( Site 0203)
      • Austin, Texas, United States, 78759
        • Velocity Clinical Research, Austin ( Site 0201)
      • Corpus Christi, Texas, United States, 78404
        • Pinnacle Clinical Research-Corpus Christi ( Site 0267)
      • Dallas, Texas, United States, 75230
        • Zenos Clinical Research ( Site 0240)
      • Edinburg, Texas, United States, 78539
        • South Texas Research Institute ( Site 0226)
      • Houston, Texas, United States, 77079
        • Houston Research Institute ( Site 0221)
      • San Antonio, Texas, United States, 78215
        • American Research Corporation ( Site 0234)
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, LLC-Clinical Research ( Site 0252)
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229)
      • Waco, Texas, United States, 76710
        • Impact Research Institute ( Site 0227)
    • Utah
      • Holladay, Utah, United States, 84117
        • Olympus Family Medicine/CCT Research ( Site 0266)
      • South Ogden, Utah, United States, 84405
        • South Ogden Family Medicine/ CCT Research ( Site 0255)

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has body mass index (BMI) ≥25 kg/m^2 (≥23 kg/m^2 for Asian participants) AND has stable weight, defined as ≤5% gain or loss of body weight for at least 3 months before screening
  • 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:

The main exclusion criteria include but are not limited to the following

  • Has a history or evidence of chronic liver disease other than Metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic dysfunction-associated steatohepatitis (MASH)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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 Names:
  • MK-6024
  • HM12525A
  • JNJ-64565111
Experimental: 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.
Drug: 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 Names:
  • MK-6024
  • HM12525A
  • JNJ-64565111
Experimental: 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.
Drug: 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 Names:
  • MK-6024
  • HM12525A
  • JNJ-64565111

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Relative Reduction From Baseline in Liver Fat Content at Week 28
Time Frame: Baseline and Week 28
Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented.
Baseline and Week 28
Percentage of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to Week 32
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented.
Up to Week 32
Percentage of Participants Who Discontinued Study Intervention Due to an AE
Time Frame: Up to Week 28
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented.
Up to Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline in Body Weight at Week 28
Time Frame: Baseline and Week 28
Body weight in kilograms was measured using a standardized, digital scale. Mean percent change in body weight from Baseline to Week 28 = (Week 28 - Baseline) / Baseline x 100%. The LS mean percent change from baseline in body weight at 28 weeks is presented.
Baseline and Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp and Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Actual)

June 27, 2025

Study Completion (Actual)

June 27, 2025

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6024-016
  • MK-6024-016 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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