About this trial
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.
Eligibility criteria
Qualifiers
Participants aged between 18 and 75 years at enrolment.
Participants with history or presence of at least two components of metabolic syndrome.
Liver biopsy consistent with cirrhosis (fibrosis stage 4).
Disqualifiers
Participants with other chronic liver diseases.
Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.
History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.
Trial design
Treatments tested in this trial
- Efimosfermin alfa
- Placebo