Clinical Trials

Overview

About this study

The purpose of this study is evaluation of efruxifermin (EFX) in subjects with compensated cirrhosis due to NASH/MASH.

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the clinical benefit and safety of EFX in subjects with compensated cirrhosis due to NASH/MASH.

The study will enroll in 2 cohorts. Cohort 1 will enroll approximately 750 subjects with biopsy-proven compensated cirrhosis due to NASH/MASH. Cohort 2 will enroll approximately 400 subjects with a clinical diagnosis of compensated cirrhosis due to NASH/MASH.
Evaluation of the clinical outcomes primary endpoint will occur when a pre-specified number of adjudicated events has been accrued, which is anticipated to be approximately 156 weeks. This time frame may be extended until the prespecified number of events has accrued.
A histology primary endpoint analysis will occur after all subjects in Cohort 1 have completed the Histology Primary Endpoint Treatment Duration (i.e., completed 96 weeks of treatment or permanently discontinued from the study prior to Week 96). For evaluation of longer-term safety and efficacy, all subjects will continue to receive their assigned treatment until the pre-specified number of adjudicated events has been accrued.
Subjects meeting the study’s eligibility criteria will be randomly assigned in a 1:1 ratio into 1 of 2 treatment groups.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

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