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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT05877547

Run by

Merck Sharp & Dohme LLC

People needed

381

Starts

2023-06-23

Expected to finish

2025-12-29

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
• No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
• Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)

You may not qualify if…

• History of liver disease other than NASH
• History or evidence of cirrhosis
• History of pancreatitis
• History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
• History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
• Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack

Where it is running

• The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289) — Peoria, Arizona, United States
• The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218) — Tucson, Arizona, United States
• Del Sol Research Management, LLC ( Site 3211) — Tucson, Arizona, United States
• Om Research - Apple Valley ( Site 3244) — Apple Valley, California, United States
• Om Research LLC ( Site 3245) — Camarillo, California, United States
• Velocity Clinical Research, Gardena ( Site 3225) — Gardena, California, United States
• Velocity Clinical Research, Huntington Park ( Site 3217) — Huntington Park, California, United States
• Velocity Clinical Research, San Diego ( Site 3226) — La Mesa, California, United States
• Om Research LLC ( Site 3229) — Lancaster, California, United States
• Velocity Clinical Research, Westlake ( Site 3216) — Los Angeles, California, United States
• Velocity Clinical Research, Panorama City ( Site 3214) — Panorama City, California, United States
• California Liver Research Institute ( Site 3232) — Pasadena, California, United States
• Clinical Trials Research ( Site 3230) — Sacramento, California, United States
• Excel Medical Clinical Trials ( Site 3246) — Boca Raton, Florida, United States
• Synergy Healthcare ( Site 3286) — Bradenton, Florida, United States
• Synergy Healthcare LLC ( Site 3290) — Brandon, Florida, United States
• Top Medical Research ( Site 3209) — Cutler Bay, Florida, United States
• Covenant Metabolic Specialists, LLC ( Site 3231) — Fort Myers, Florida, United States
• Velocity Clinical Research, Hallandale Beach ( Site 3241) — Hallandale, Florida, United States
• Indago Research & Health Center, Inc ( Site 3207) — Hialeah, Florida, United States
• Sweet Hope Research Specialty, Inc-Research ( Site 3200) — Hialeah, Florida, United States
• Florida Research Institute ( Site 3243) — Lakewood Rch, Florida, United States
• Genoma Research Group ( Site 3242) — Miami, Florida, United States
• Floridian Clinical Research, LLC ( Site 3203) — Miami Lakes, Florida, United States
• The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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