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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

No Placebo-Only Group

Summary

This trial is testing a new medication called efinopegdutide to see if it can reduce liver fat in people with Non-Alcoholic Fatty Liver Disease (NAFLD). The goal is to find out if it works better than an existing drug, semaglutide. Researchers hope that efinopegdutide will help improve liver health by reducing fat content.

Eligible Conditions

Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~29 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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%

Decreased appetite

17%

Diarrhoea

17%

Vomiting

13%

Abdominal pain

11%

COVID-19

10%

Abdominal pain upper

Gastrooesophageal reflux disease

Dyspepsia

Headache

Abdominal distension

Lipase increased

Alanine aminotransferase increased

Dizziness

Flatulence

Urinary tract infection

Calculus urinary

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Efinopegdutide

Semaglutide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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