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

NCT06482112

CompletedPhase 2

Sponsor: Merck Sharp & Dohme LLC

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

Interventions: Efinopegdutide

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Chandler, Arizona, United States
Peoria, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Camarillo, California, United States
Escondido, California, United States
Gardena, California, United States
Huntington Park, California, United States
Pasadena, California, United States
San Diego, California, United States
Santa Ana, California, United States
Van Nuys, California, United States
Boca Raton, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Miami Lakes, Florida, United States
Dalton, Georgia, United States
Rockville, Maryland, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Inwood, New York, United States
Morehead City, North Carolina, United States
Arlington, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Edinburg, Texas, United States
Houston, Texas, United States
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