A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

NCT05877547 · Completed

Last updated 2026-05-28

This clinical trial is testing the drug efinopegdutide in adults with precirrhotic nonalcoholic steatohepatitis (NASH) to see if it can improve liver condition without worsening fibrosis after 52 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, triple-blind treatment study

Participants 381 people

Who can join Ages 18–80 · all sexes

Timeline Started 2023-06 · est. completion 2025-12

Where 175 sites · Austria, Belgium, Canada, Chile, China, Colombia, Czechia, France, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Portugal, Puerto Rico, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT05877547 ↗

Description as written by the study sponsor.

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

Treatments tested

Efinopegdutide also known as MK-6024, HM12525A, JNJ-64565111 Drug

Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg
Semaglutide also known as Wegovy Drug

SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg
Placebo Drug

SC injection of matching placebo

Main thing measured	Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52
Sponsor	Merck Sharp & Dohme LLC
Conditions studied	Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05877547 ↗