Recruiting NCT06528314

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

Phase III Interventional NASH - Nonalcoholic Steatohepatitis MASH - Metabolic Dysfunction-Associated Steatohepatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Efruxifermin, Placebo.
Who it may be relevant to: Registry conditions: NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Overview

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.

Interventions

Drug Efruxifermin
Administered by subcutaneous injection
Drug Placebo
Administered by subcutaneous injection

Primary outcome measures

Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. [Time frame: 5 years]
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis [Time frame: 96 Weeks]

Secondary outcome measures (12)

Change from baseline of non-invasive markers of liver fibrosis [Time frame: 96 Weeks, 5 Years]
Change from baseline of non-invasive markers of liver fibrosis [Time frame: 96 Weeks, 5 Years]
Change from baseline of non-invasive markers of liver fibrosis [Time frame: 96 Weeks, 5 Years]
Change from baseline of markers of liver injury [Time frame: 96 Weeks, 5 Years]
Change from baseline of lipoproteins [Time frame: 96 Weeks, 5 Years]
Change from baseline of markers of insulin sensitivity and glycemic control [Time frame: 96 Weeks, 5 Years]
Change from baseline of markers of insulin sensitivity and glycemic control [Time frame: 96 Weeks, 5 Years]
Change from baseline of markers of insulin sensitivity and glycemic control [Time frame: 96 Weeks, 5 Years]
Change from baseline of markers of insulin sensitivity and glycemic control [Time frame: 96 Weeks, 5 Years]
Change from baseline of markers of insulin sensitivity and glycemic control [Time frame: 96 Weeks, 5 Years]
Change from baseline of body weight (kg) [Time frame: 96 Weeks, 5 Years]
Safety and tolerability of EFX through the reporting of extent of exposure (weeks) [Time frame: From first dose through end of study (up to 5 Years)]

Eligibility criteria

Inclusion criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment