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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 2

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

Treatments: Drug: Efinopegdutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06482112

MK-6024-016 (Other Identifier)

6024-016

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Efinopegdutide Q1W 10 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Efinopegdutide

Efinopegdutide Q2W 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Efinopegdutide

Efinopegdutide Q2W 15 mg

Experimental group

Description:

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.

Treatment:

Drug: Efinopegdutide