Efimosfermin for Fatty Liver Disease

Recruiting at23 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boston Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

Research Team

Eligibility Criteria

This trial is for adults aged 18-75 with compensated cirrhosis due to metabolic dysfunction associated steatohepatitis (MASH) and stage F4 fibrosis. Participants must have at least two components of metabolic syndrome and be able to give informed consent. Those with type 1 diabetes, other causes of chronic liver disease, or decompensated liver disease cannot join.

Inclusion Criteria

I am between 18 and 75 years old.

I have at least two symptoms of metabolic syndrome.

Other inclusion criteria may apply.

Exclusion Criteria

I have a history of type 1 diabetes.

I have chronic liver disease but no history of severe liver failure.

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)

Treatment Details

Interventions

• Efimosfermin Alfa (Cytokine Therapy)

Trial Overview The study tests the safety and potential benefits of Efimosfermin Alfa in individuals with MASH-related cirrhosis. It compares this new treatment against a placebo while also studying how the body processes the drug.

Participant Groups

Group I: Efimosfermin (Dose 2) Experimental Treatment 1 Intervention

Participants will receive efimosfermin (Dose 2) Q4W.

Group II: Efimosfermin (Dose 1) Experimental Treatment 1 Intervention

Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo Q4W.

Who Is Running the Clinical Trial?

Boston Pharmaceuticals

Lead Sponsor

Trials

12

Recruited

910+