MedTrace Logo

A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

NCT04944992 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-11-15

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Efinopegdutide 20 mg/mL

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

DRUG

Semaglutide 1.34 mg/mL

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-04
Primary Completion
2022-10-19
Completion
2022-10-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • France
  • Israel
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT04944992 on ClinicalTrials.gov