A Pivotal Clinical Study to Investigate the 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 study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.

Eligibility criteria

Qualifiers

Participants aged between 18 and 75 years at enrollment.

Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.

Participants with history or presence of at least two components of metabolic syndrome.

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 complications.

Participants with 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

1,740 Participants
are divided into 2 treatment groups

Sponsors and collaborators