drugset / Trial / NCT05877547

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

NCT05877547 ↗

Phase 2 Completed 381 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-06-23
Primary completion
2025-12-29
Completion
2025-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Efinopegdutide Protein / enzyme biologic 4 mg Subcutaneous
Subject Efinopegdutide Protein / enzyme biologic 7 mg Subcutaneous
Subject Efinopegdutide Protein / enzyme biologic 10 mg Subcutaneous
Comparator Semaglutide Peptide 2.4 mg Subcutaneous