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

Launched by BOSTON PHARMACEUTICALS · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called efimosfermin alfa to see how safe it is, how well it works, and how the body processes it in people with a liver condition known as metabolic dysfunction-associated steatohepatitis (MASH) who also have compensated cirrhosis. This means that while the liver has some serious damage, it is still functioning well enough that the patient does not have symptoms of liver failure. The trial is not currently recruiting participants, but it will involve adults aged 18 to 75 who have been diagnosed with MASH and have certain health conditions related to metabolic syndrome.

To be eligible for this study, participants must be able to understand and sign a consent form, and they need to have a liver biopsy confirming their condition. However, individuals with other types of chronic liver disease or significant liver damage that causes symptoms won't be included. Participants can expect to undergo regular health assessments and monitoring during the trial, which aims to gather important information that could help improve treatment for this condition in the future.

Gender

ALL

Eligibility criteria

• 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.