A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) MASH

ID#: NCT06920043

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: April 09, 2025

End Date: November 01, 2027

Contact Information:
Patricia Mendez, MD
617-826-0300
Summary: 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.
Eligibility:

Inclusion Criteria:

- Ability to understand and sign a written informed consent form (ICF)

- Age 18 through 75 years at enrollment

- History or presence of 2 or more of the 5 components of metabolic syndrome

- Liver biopsy confirmation of MASH consistent with stage F4 fibrosis

- Other inclusion criteria may apply.

Exclusion Criteria:

- Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease

- History of type 1 diabetes

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

- Other exclusion criteria may apply.
Find a Clinical Trial Find Cancer Clinical Trials