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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

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

Study Details

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 Dates

Start date

Jul 29, 2024

Status verified

May 2026

Primary completion

Jun 27, 2025

Completion

Jun 27, 2025

Study Design

Enrollment

124 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Efinopegdutide Q1W 10 mg
  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.
• Experimental: Efinopegdutide Q2W 10 mg
  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.
• Experimental: Efinopegdutide Q2W 15 mg
  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.

Primary Outcome Measure

Mean Relative Reduction From Baseline in Liver Fat Content at Week 28 [ Time Frame: Baseline and Week 28 ]

Locations (36)

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