Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 2NCT06482112
Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
A Phase 2 study testing Efinopegdutide in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Non-alcoholic Fatty Liver Disease, run by Merck Sharp & Dohme LLC at 39 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease
- What is being tested?
- Efinopegdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 29 Jul 2024to 27 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States36 sites
Texas Clinical Research Institute ( Site 0230)
Arlington, Texas, 76012
Pinnacle Clinical Research ( Site 0203)
Austin, Texas, 78757
Velocity Clinical Research, Austin ( Site 0201)
Austin, Texas, 78759
Excel Medical Clinical Trials ( Site 0268)
Boca Raton, Florida, 33434
Om Research LLC ( Site 0207)
Camarillo, California, 93012
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0
Chandler, Arizona, 85224
Pinnacle Clinical Research-Corpus Christi ( Site 0267)
Corpus Christi, Texas, 78404
Zenos Clinical Research ( Site 0240)
Dallas, Texas, 75230
Southeast Clinical Research Center ( Site 0223)
Dalton, Georgia, 30720
South Texas Research Institute ( Site 0226)
Edinburg, Texas, 78539
Gastroenterology and Liver Institute ( Site 0263)
Escondido, California, 92025
Velocity Clinical Research, Gardena ( Site 0235)
Gardena, California, 90247
AGA Clinical Trials ( Site 0274)
Hialeah, Florida, 33012
Neoclinical Research ( Site 0275)
Hialeah, Florida, 33016
Olympus Family Medicine/CCT Research ( Site 0266)
Holladay, Utah, 84117
Homestead Associates in Research, Inc. ( Site 0243)
Homestead, Florida, 33033
Houston Research Institute ( Site 0221)
Houston, Texas, 77079
Velocity Clinical Research, Huntington Park ( Site 0210)
Huntington Park, California, 90255
Basil Clinical ( Site 0246)
Inwood, New York, 11096
The Machuca Foundation ( Site 0218)
Las Vegas, Nevada, 89101
Excel Clinical Research, LLC ( Site 0200)
Las Vegas, Nevada, 89109
Floridian Clinical Research, LLC ( Site 0208)
Miami Lakes, Florida, 33016
Lucas Research, Inc ( Site 0204)
Morehead City, North Carolina, 28557
California Liver Research Institute ( Site 0216)
Pasadena, California, 91105
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)
Peoria, Arizona, 85381
Velocity Clinical Research Rockville ( Site 0245)
Rockville, Maryland, 20854
American Research Corporation ( Site 0234)
San Antonio, Texas, 78215
Clinical Trials of Texas, LLC-Clinical Research ( Site 0252)
San Antonio, Texas, 78229
Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229)
San Antonio, Texas, 78229
Acclaim Clinical Research ( Site 0241)
San Diego, California, 92120
Velocity Clinical Research, Santa Ana ( Site 0250)
Santa Ana, California, 92704
South Ogden Family Medicine/ CCT Research ( Site 0255)
South Ogden, Utah, 84405
Arizona Liver Health ( Site 0211)
Tucson, Arizona, 85712
Del Sol Research Management, LLC ( Site 0209)
Tucson, Arizona, 85715
Velocity Clinical Research, Panorama City ( Site 0228)
Van Nuys, California, 91405
Impact Research Institute ( Site 0227)
Waco, Texas, 76710
Puerto Rico3 sites
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104)
Caguas, 00726
Klinical Investigations Group-Clinical Research ( Site 0100)
San Juan, 00909
Pan American Center for Oncology Trials - Ciudadela ( Site 0101)
San Juan, 00909
About this study
Official title: 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.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, Liver Disease
- Being tested
- Efinopegdutide
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfinopegdutideDrug
Also called MK-6024, HM12525A, JNJ-64565111
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
| Study group | Role | What they receive |
|---|---|---|
| Efinopegdutide Q1W 10 mg | Active comparator | 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. Receives: Drug: Efinopegdutide |
| Efinopegdutide Q2W 10 mg | Experimental | 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. Receives: Drug: Efinopegdutide |
| Efinopegdutide Q2W 15 mg | Experimental | 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. Receives: Drug: Efinopegdutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Relative Reduction From Baseline in Liver Fat Content at 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.
Measured: Baseline and Week 28
Percentage of Participants Who Experienced an Adverse Event (AE)
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.
Measured: Up to Week 32
Percentage of Participants Who Discontinued Study Intervention Due to an AE
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.
Measured: Up to Week 28
Secondary outcomes (1)
Mean Percent Change From Baseline in Body Weight at 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.
Measured: Baseline and Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start29 Jul 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp and Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482112
- Sponsor's protocol ID
- 6024-016
- Other IDs
- MK-6024-016
- Status last verified
- May 2026
- First submitted
- 26 Jun 2024
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06482112
- Acronym / sponsor ID
- 6024-016
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Efinopegdutide Q1W 10 mg | Active comparator | Drug: EfinopegdutideParticipants 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 Q2W 10 mg | Experimental | Drug: EfinopegdutideParticipants 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 Q2W 15 mg | Experimental | Drug: EfinopegdutideParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EfinopegdutideAlso: MK-6024, HM12525A, JNJ-64565111SC 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 | Drug | Efinopegdutide Q1W 10 mg, Efinopegdutide Q2W 10 mg, Efinopegdutide Q2W 15 mg |
Primary outcome
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.
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.
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.
1 secondary outcome
Mean Percent Change From Baseline in Body Weight at Week 28
Time frame: Baseline and Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Enrolling by invitation
Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp and Dohme LLC
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efinopegdutide in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Non-alcoholic Fatty Liver Disease, run by Merck Sharp & Dohme LLC at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Relative Reduction From Baseline in Liver Fat Content at Week 28 (time frame: Baseline and Week 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.