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

Efinopegdutide for Nonalcoholic Steatohepatitis (NASH)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you have NASH?
Be older than 18 years old
Must not have
Have you ever had a liver disease other than NASH?
Do you have uncontrolled type II diabetes?
Timeline
Screening 10 weeks
Treatment 12 months
Follow Up 9 weeks
Awards & highlights

Study Summary

This trial is testing a drug to help people with NASH, looking at safety, effectiveness, and how well it's tolerated.

Who is the study for?
This trial is for individuals with NASH, a type of liver disease where fat builds up in the liver. Participants should not have other types of liver diseases, uncontrolled Type II diabetes, or a history of cirrhosis or pancreatitis. Those who've had bariatric surgery within the last 5 years are also excluded.Check my eligibility
What is being tested?
The study tests how effective Efinopegdutide is compared to a placebo in treating NASH. It aims to see if Efinopegdutide can reduce signs of NASH without worsening liver scarring. Semaglutide's effects may also be observed as part of the study.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions to drugs like Efinopegdutide could include gastrointestinal issues (nausea, vomiting), injection site reactions, and potential changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have NASH.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had liver diseases other than NASH.
Select...
My type II diabetes is not under control.
Select...
I have not had bariatric surgery in the last 5 years.
Select...
I have never had cirrhosis or pancreatitis.

Timeline

Screening ~ 10 weeks
Treatment ~ 12 months
Follow Up ~9 weeks
This trial's timeline: 10 weeks for screening, 12 months for treatment, and 9 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
Percentage of Participants Discontinuing Study Medication Due to an AE
Percentage of Participants Who Experienced an Adverse Event (AE)
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52
Secondary outcome measures
Change from Baseline in Body Weight At Week 52
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
29%
Nasopharyngitis
9%
Constipation
9%
Nausea
8%
Upper respiratory tract inflammation
6%
Back pain
6%
Diarrhoea
5%
Decreased appetite
3%
Influenza
3%
Diabetic retinopathy
2%
Atrioventricular block second degree
2%
Abdominal discomfort
2%
Vomiting
2%
Angina pectoris
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dulaglutide 0.75 mg
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Efinopegdutide 7mgExperimental Treatment1 Intervention
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.
Group II: Efinopegdutide 4mgExperimental Treatment1 Intervention
Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.
Group III: Efinopegdutide 10mgExperimental Treatment1 Intervention
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.
Group IV: Semaglutide 2.4 mgActive Control1 Intervention
Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.
Group V: PlaceboPlacebo Group1 Intervention
Placebo administered by SC injection once weekly for 52 weeks

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,846 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
518 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,919 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
206 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Efinopegdutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05877547 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo, Efinopegdutide 7mg, Efinopegdutide 4mg, Efinopegdutide 10mg, Semaglutide 2.4 mg
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Efinopegdutide Highlights & Side Effects. Trial Name: NCT05877547 — Phase 2
Efinopegdutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05877547 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05877547 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for participation in this experiment?

"This clinical trial is recruiting patients aged between 18 and 80. Furthermore, there are 33 trials for those under the age of majority and 365 studies for seniors over 65 that they may be interested in participating in."

Answered by AI

What is the projected enrollment of this research effort?

"To facilitate this research trial, Merck Sharp & Dohme LLC must recruit 300 appropriate participants. This is being done across two Velocity Clinical Research locations in East Syracuse and Dallas respectively."

Answered by AI

How many clinical sites have been enlisted to execute the trial?

"Currently, 5 medical centres are the main sites of this study. East Syracuse, Dallas and San Antonio being three among them. To ensure minimal commute costs for those who take part in it; we advise selecting a site near to where you live."

Answered by AI

Does this research endeavor have open enrollment for participants?

"The data hosted on clinicaltrials.gov reports that this medical trial, first advertised on June 23rd 2023, is actively recruiting participants. It was last updated on July 6th 2023."

Answered by AI

Is it possible to be admitted into this research endeavor?

"This clinical trial is enrolling 300 individuals between 18-80 years old who suffer from the hepatic condition Non-Alcoholic Fatty Liver Disease (NAFLD). To be eligible, a patient must have histological confirmation with an NAFLD Activity Score of 4 or higher; they cannot have Type 2 diabetes Mellitus and if they do, their A1C must remain at 9% or lower. In South Korea specifically, participants can range in age from 19 to 80."

Answered by AI

Has the Federal Drug Administration given their seal of approval to Efinopegdutide 10mg?

"Although there is evidence of Efinopegdutide 10mg's safety, as this trial remains in Phase 2, we assigned it a score of 2 out of 3."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Velocity Clinical Research, Gardena ( Site 3225)
New York Gastroenterology Associates ( Site 3252)
Other
Velocity Clinical Research, Panorama City
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

Insight into my health. I want to get my liver healthy. Because thru my Medicare will take forever to get anything done..if at all!!
PatientReceived 1 prior treatment
I’ve been on Wegovy and Ozempic since Nov 22 and I’ve lost like less than 10lb. I have super high cholesterol. And I’m not eating enough to gain weight or bad enough for my cholesterol to be this high.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Velocity Clinical Research, Panorama City: < 24 hours
  2. Velocity Clinical Research, Dallas ( Site 3220): < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
2023. "A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05877547.
All > Nonalcoholic Fatty Liver Disease > Tucson
~197 spots leftby Dec 2025
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