A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

NCT04944992 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety and effectiveness of the drug efinopegdutide (MK-6024) in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) to see how it affects liver fat over 24 weeks.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 145 people

Who can join Ages 18–70 · all sexes

Timeline Started 2021-08 · est. completion 2022-10

Where 69 sites · Argentina, Australia, Canada, France, Israel, Italy, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States

What this study is testing ClinicalTrials.gov NCT04944992 ↗

Description as written by the study sponsor.

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

Treatments tested

Efinopegdutide 20 mg/mL also known as MK-6024, HM12525A, JNJ-64565111 Drug

Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
Semaglutide 1.34 mg/mL also known as Ozempic® Drug

Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg

Main thing measured	Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks
Sponsor	Merck Sharp & Dohme LLC
Conditions studied	Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04944992 ↗