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

NCT06482112 | Completed Phase 2 FDA Drug

• 2 other identifiers: 6024-016MK-6024-016
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 39

Brief 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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease; Nonalcoholic Fatty Liver Disease; Liver Disease

Outcome Measures

Primary Outcomes (3)

• Mean relative reduction from baseline in liver fat content (LFC) at Week 28

  LFC will be 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%. Mean relative reduction from baseline in LFC will be presented.

  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 will be presented.

  Up to Week 32

• Percentage of pariticpants 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 will be presented.

  Up to Week 28

Secondary Outcomes (1)

• Mean percent change from baseline in body weight at Week 28

  Baseline and Week 28

Study Arms (3)

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.

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.

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.

Drug: Efinopegdutide

Interventions

Efinopegdutide DRUG

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

Also known as: MK-6024, HM12525A, JNJ-64565111

Efinopegdutide Q1W 10 mg; Efinopegdutide Q2W 10 mg; Efinopegdutide Q2W 15 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (39)

The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0

Chandler, Arizona, 85224, United States

Location

The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)

Peoria, Arizona, 85381, United States

Location

Arizona Liver Health ( Site 0211)

Tucson, Arizona, 85712, United States

Location

Del Sol Research Management, LLC ( Site 0209)

Tucson, Arizona, 85715, United States

Location

Om Research LLC ( Site 0207)

Camarillo, California, 93012, United States

Location

Gastroenterology and Liver Institute ( Site 0263)

Escondido, California, 92025, United States

Location

Velocity Clinical Research, Gardena ( Site 0235)

Gardena, California, 90247, United States

Location

Velocity Clinical Research, Huntington Park ( Site 0210)

Huntington Park, California, 90255, United States

Location

California Liver Research Institute ( Site 0216)

Pasadena, California, 91105, United States

Location

Acclaim Clinical Research ( Site 0241)

San Diego, California, 92120, United States

Location

Velocity Clinical Research, Santa Ana ( Site 0250)

Santa Ana, California, 92704, United States

Location

Velocity Clinical Research, Panorama City ( Site 0228)

Van Nuys, California, 91405, United States

Location

Excel Medical Clinical Trials ( Site 0268)

Boca Raton, Florida, 33434, United States

Location

AGA Clinical Trials ( Site 0274)

Hialeah, Florida, 33012, United States

Location

Neoclinical Research ( Site 0275)

Hialeah, Florida, 33016, United States

Location

Homestead Associates in Research, Inc. ( Site 0243)

Homestead, Florida, 33033, United States

Location

Floridian Clinical Research, LLC ( Site 0208)

Miami Lakes, Florida, 33016, United States

Location

Southeast Clinical Research Center ( Site 0223)

Dalton, Georgia, 30720, United States

Location

Velocity Clinical Research Rockville ( Site 0245)

Rockville, Maryland, 20854, United States

Location

The Machuca Foundation ( Site 0218)

Las Vegas, Nevada, 89101, United States

Location

Excel Clinical Research, LLC ( Site 0200)

Las Vegas, Nevada, 89109, United States

Location

Basil Clinical ( Site 0246)

Inwood, New York, 11096, United States

Location

Lucas Research, Inc ( Site 0204)

Morehead City, North Carolina, 28557, United States

Location

Texas Clinical Research Institute ( Site 0230)

Arlington, Texas, 76012, United States

Location

Pinnacle Clinical Research ( Site 0203)

Austin, Texas, 78757, United States

Location

Velocity Clinical Research, Austin ( Site 0201)

Austin, Texas, 78759, United States

Location

Pinnacle Clinical Research-Corpus Christi ( Site 0267)

Corpus Christi, Texas, 78404, United States

Location

Zenos Clinical Research ( Site 0240)

Dallas, Texas, 75230, United States

Location

South Texas Research Institute ( Site 0226)

Edinburg, Texas, 78539, United States

Location

Houston Research Institute ( Site 0221)

Houston, Texas, 77079, United States

Location

American Research Corporation ( Site 0234)

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, LLC-Clinical Research ( Site 0252)

San Antonio, Texas, 78229, United States

Location

Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229)

San Antonio, Texas, 78229, United States

Location

Impact Research Institute ( Site 0227)

Waco, Texas, 76710, United States

Location

Olympus Family Medicine/CCT Research ( Site 0266)

Holladay, Utah, 84117, United States

Location

South Ogden Family Medicine/ CCT Research ( Site 0255)

South Ogden, Utah, 84405, United States

Location

San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104)

Caguas, 00726, Puerto Rico

Location

Klinical Investigations Group-Clinical Research ( Site 0100)

San Juan, 00909, Puerto Rico

Location

Pan American Center for Oncology Trials - Ciudadela ( Site 0101)

San Juan, 00909, Puerto Rico

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Study Officials

• Medical Director

  Merck Sharp and Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: July 29, 2024
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (36); PR (3)