A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrohosis Due to Nash/Mash

RV

Raj Vuppalanchi, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years - 80 Years Gender: All Genders Phase: 3 2 Locations

Brief Description

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed Description

PRIMARY OUTCOME:

  • Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events
  • Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

Eligibility of study

Inclusion Criteria:

  • Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  • Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Exclusion Criteria:

  • 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

Other inclusion and exclusion criteria may apply

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.