Efinopegdutide for Fatty Liver Disease

Palo Alto (17 mi)

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.

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.

Exclusion Criteria

I have had pancreatitis before.

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

I experience symptoms of high blood sugar.

I have a chronic liver condition that is not MASLD or MASH.

I had weight loss surgery less than 5 years ago or have a known stomach emptying issue.

I have obesity due to a known medical reason.

I have severe liver problems, including fluid in the abdomen or bleeding varices.

Treatment Details

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.

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.