A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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 non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).

The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Eligibility

Primary outcome measure(s)

• Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis — 52 Weeks
  Based on NAS (scored by 0-3 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
• Event-free survival — 240 Weeks
  Based on time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality.

Trial sites (356)

+ 316 more sites — see the full list on the official registry below.

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