Efinopegdutide for Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

+39 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.

Research Team

Medical Director

Principal Investigator

Merck Sharp and Dohme LLC

Eligibility Criteria

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.

Inclusion Criteria

I either don't have type 2 diabetes, or if I do, it's well-controlled with diet or medication.

Has body mass index (BMI) ≥25 kg/m^2 (≥23 kg/m^2 for Asian participants) AND has stable weight, defined as ≤5% gain or loss of body weight for at least 3 months before screening

Exclusion Criteria

I haven't had major heart or stroke issues in the last 6 months.

I have had pancreatitis before.

I have a history of type 1 diabetes, diabetic ketoacidosis, or diabetes due to pancreas surgery.

Treatment Details

Interventions

• Efinopegdutide (Other)

Trial Overview 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.

Participant Groups

Group I: Efinopegdutide Q2W 15 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 mg Active Control 1 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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University