← Back to Search

Other

Efinopegdutide for Fatty Liver Disease

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
Be older than 18 years old
Must not have
Has a history of pancreatitis
Has a history of type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 32
Awards & highlights

Summary

"This trial will compare how effective efinopegdutide is in reducing liver fat content when administered every 2 weeks versus once a week for 28 weeks. The study will also assess the safety

Who is the study for?
This trial is for adults with metabolic dysfunction-associated steatotic liver disease (MASLD), which includes conditions like fatty liver disease and non-alcoholic fatty liver disease. Participants should have a certain level of fat in their livers but otherwise be generally healthy.
What is being tested?
The study is testing the drug efinopegdutide, given as an injection. It will compare two dosing schedules: once every two weeks (Q2W) versus once weekly (Q1W). The focus is on how well each schedule reduces liver fat content over 28 weeks and how safe and tolerable they are.
What are the potential side effects?
While specific side effects aren't listed here, common ones for similar treatments include injection site reactions, gastrointestinal issues, fatigue, headache, and potential allergic reactions. Safety and tolerability will be closely monitored.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had pancreatitis before.
Select...
I have a history of type 1 diabetes, diabetic ketoacidosis, or diabetes due to pancreas surgery.
Select...
I experience symptoms of high blood sugar.
Select...
I have a chronic liver condition that is not MASLD or MASH.
Select...
I had weight loss surgery less than 5 years ago or have a known stomach emptying issue.
Select...
I have obesity due to a known medical reason.
Select...
I have severe liver problems, including fluid in the abdomen or bleeding varices.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 32 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) at Week 28
Percentage of pariticpants who discontinued study intervention due to an AE
Percentage of participants who experienced an adverse event (AE)
Secondary study objectives
Mean percent change from baseline in body weight at Week 28

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Efinopegdutide Q2W 15 mgExperimental Treatment1 Intervention
Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Group II: Efinopegdutide Q2W 10 mgExperimental Treatment1 Intervention
Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.
Group III: Efinopegdutide Q1W 10 mgActive Control1 Intervention
Participants will receive efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,878 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
894 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical DirectorStudy DirectorMerck Sharp and Dohme LLC
2,834 Previous Clinical Trials
8,079,675 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
586 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~70 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top