A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: liver, addiction
- Who it enrolls
- age 18 Years to 80 Years; excludes diabetes; no BMI minimum stated; conditions: Non-alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Fatty Liver Disease
- Interventions
- Efinopegdutide; Semaglutide; Placebo
- Conditions
- Non-alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
- Phase and size
- Phase 2 · 381 participants
- Dates
- Start 2023-06-23
Primary completion 2025-12-29 - Sponsor
- Merck Sharp & Dohme LLC (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52Week 52
- Percentage of Participants Who Experienced an Adverse Event (AE)Up to 60 weeks
- Percentage of Participants Discontinuing Study Medication Due to an AEUp to 52 weeks
02Eligibility
Who can take part
Inclusion Criteria: * 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) Exclusion Criteria: * 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
03Change log
Registry changes
No changes recorded since the trial was added.