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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
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 moreSide effects data
From 2022 Phase 2 trial • 145 Patients • NCT0494499228%
Nausea
17%
Constipation
17%
Decreased appetite
17%
Diarrhoea
17%
Vomiting
13%
Abdominal pain
11%
COVID-19
10%
Abdominal pain upper
8%
Gastrooesophageal reflux disease
8%
Dyspepsia
7%
Headache
6%
Abdominal distension
6%
Lipase increased
6%
Alanine aminotransferase increased
6%
Dizziness
6%
Flatulence
6%
Urinary tract infection
1%
Calculus urinary
1%
Fatigue
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,351 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
4,000 Previous Clinical Trials
5,181,687 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
854 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,880 Previous Clinical Trials
8,084,975 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
546 Patients Enrolled for Non-alcoholic Fatty Liver Disease
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