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Glucagon-like peptide-1 (GLP-1) receptor agonist

Efinopegdutide 20 mg/mL for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~29 weeks
Awards & highlights

Summary

This trial is testing if efinopegdutide is better than semaglutide at reducing liver fat content in people with NAFLD.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~29 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~29 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks
Percentage of Participants Who Discontinued Study Intervention Due to an AE
Percentage of Participants Who Experienced an Adverse Event (AE)
Secondary outcome measures
Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks
Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks
Mean Percent Change From Baseline in Body Weight After 24 Weeks
+5 more

Side effects data

From 2022 Phase 2 trial • 145 Patients • NCT04944992
28%
Nausea
17%
Constipation
17%
Diarrhoea
17%
Vomiting
17%
Decreased appetite
13%
Abdominal pain
11%
COVID-19
10%
Abdominal pain upper
8%
Dyspepsia
8%
Gastrooesophageal reflux disease
7%
Headache
6%
Abdominal distension
6%
Flatulence
6%
Urinary tract infection
6%
Alanine aminotransferase increased
6%
Lipase increased
6%
Dizziness
1%
Calculus urinary
1%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efinopegdutide
Semaglutide

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EfinopegdutideExperimental Treatment1 Intervention
Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.
Group II: SemaglutideActive Control1 Intervention
Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efinopegdutide 20 mg/mL
2021
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,867 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
224 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,068,118 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
749 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,070,185 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
441 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~37 spots leftby Jul 2025