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Clinical Trials List

Protocol NumberMK-6024-013
NCT Number(ClinicalTrials.gov Identfier)NCT05877547
Active

2023-06-01 - 2026-12-31

Phase II

Recruiting7

ICD-10K74.4

Secondary biliary cirrhosis

ICD-10K75.81

Nonalcoholic steatohepatitis (NASH)

ICD-10K76.0

Fatty (change of) liver, not elsewhere classified

ICD-10K76.89

Other specified diseases of liver

ICD-10R16.2

Hepatomegaly with splenomegaly, not elsewhere classified

ICD-9571.8

Other chronic nonalcoholic liver disease

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TENG-YU LEE Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Jen Liu Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Chung Hsieh 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 杜思德 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳啟益 無
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Nan Cheng Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-alcoholic Fatty Liver Disease

Objectives

main purpose ‧ To assess the effect of efinopegdutide compared with placebo on the proportion of patients with NASH in remission and without worsening of fibrosis at week 52. ‧ To assess the safety and tolerability of efinopegdutide. secondary purpose ‧ To assess the effect of efinopegdutide compared with placebo on the proportion of patients with stage 1 fibrosis improvement and no worsening of steatohepatitis at week 52. ‧ To evaluate the effect of efinopegdutide compared with placebo on the mean percentage change in body weight from baseline at week 52.

Test Drug

MK-6024

Active Ingredient

Efinopegdutide

Dosage Form

Injection

Dosage

4 mg/mL；8 mg/mL；14 mg/mL；20 mg/mL

Endpoints

‧ Remission of NASH as assessed by the NASH Clinical Research Network (CRN) scoring system (scores are defined as 0-1 for inflammation, 0 for hepatocellular vacuolation, and any grade of steatosis) without worsening of fibrosis [Assessed by Blinded Independent Central Review (BICR)]
‧ Adverse events (AE)
‧ Discontinuation of trial treatment due to AE

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    360 participants

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