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NCT06482112

PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-07-29

Completion Date

2025-06-27

Last Updated

2026-06-01

Healthy Volunteers

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease Liver Disease

Interventions

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

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

Locations (39)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (39)