A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGlaxoSmithKline

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

Treatment groups

380 Participants
are divided into 3 treatment groups

Sponsors and collaborators