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

NCT05877547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Efinopegdutide

Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg

DRUG

Semaglutide

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

DRUG

Placebo

SC injection of matching placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2025-12-29
Completion
2025-12-29
FDA Drug
Yes

Countries

  • United States
  • 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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05877547 on ClinicalTrials.gov