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

Condition(s) studied

Investigational drug(s) / intervention(s)

Efruxifermin: Administered by subcutaneous injection

Placebo: Administered by subcutaneous injection

Study summary

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

Primary outcome measure(s)

• Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. — 5 years
  Measured by composite of protocol-specified clinical events
• Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis — 96 Weeks
  Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

Trial sites (331)

+ 291 more sites — see the full list on the official registry below.