A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAkero Therapeutics, Inc

About this trial

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Eligibility criteria

Qualifiers

Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of >=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities

Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Disqualifiers

Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results

Type 1 diabetes or unstable Type 2 diabetes

Any current or prior history of decompensated liver disease

Trial design

Treatments tested in this trial

  • Efruxifermin
  • Placebo

Treatment groups

2,150 Participants
are divided into 2 treatment groups

Sponsors and collaborators