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

Completed · Phase 2

Conditions studied: Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, Liver Disease

In brief

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.

Key facts

Study ID

NCT06482112

Run by

Merck Sharp & Dohme LLC

People needed

124

Starts

2024-07-29

Expected to finish

2025-06-27

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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