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Efinopegdutide for Fatty Liver Disease

Phase 2

Waitlist Available

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

No Placebo-Only Group

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:

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I have had pancreatitis before.

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

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I experience symptoms of high blood sugar.

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

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

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I have obesity due to a known medical reason.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 32

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met