CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 145 enrolled
Drug / intervention
Efinopegdutide 20 mg/mL +1 moredrug
Likely dose
Efinopegdutide 20 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04944992
NCT04944992Phase 2Completed
CompareCT.gov

A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease

Merck Sharp & Dohme LLC·interventional·Posted Jun 30, 2021·Updated Nov 15, 2023

In Brief

A Phase 2 clinical trial evaluating Efinopegdutide 20 mg/mL and Semaglutide 1.34 mg/mL for Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis. Completed, enrolled 145 participants across 69 sites in 16 countries.

Detailed Summary

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
CountriesArgentina, Australia, Canada, France, Israel, Italy, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 30, 2021
Enrollment StartAug 4, 2021
Primary CompletionOct 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.0 years ago

Interventions

Efinopegdutide 20 mg/mLdrug

Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg

Semaglutide 1.34 mg/mLdrug

Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg