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Taking people in ItalyPhase 3

Tests efruxifermin in adults with cirrhosis caused by fatty liver disease

Tests efruxifermin against a placebo in adults with cirrhosis from MASH.

Key facts

Who runs it
Akero Therapeutics, Inc
Where
Bologna, Catania, Foggia, Messina, Milan, Modena, Novara, Roma, Rozzano, San Giovanni Rotondo, and Torino, ItalySee the 11 sitesAlso in 22 other countries, 284 sites
Trial code
Registry title
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Status
Recruiting
Phase
Phase 3
People taking part
2,150 people, planned
Started
4 Oct 2024
Expected to end
Mar 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Efruxifermin
  • Placebo
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 with compensated cirrhosis (advanced liver scarring) caused by NASH/MASH, a fatty liver disease.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Compensated cirrhosis (fibrosis stage 4) due to NASH/MASH. Cohort 1 needs a biopsy and a NAS score of 3 or more, or fatty liver plus 2 current features of metabolic comorbidities. Cohort 2 can be diagnosed by biopsy or by non-invasive tests.

Main reasons for not taking part

  • Another cause of liver disease
  • Type 1 diabetes
  • Unstable Type 2 diabetes
  • Any current or past decompensated liver disease

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any current or prior history of decompensated liver disease; Other inclusion and exclusion criteria may apply
  • Type 1 diabetes or unstable Type 2 diabetes
  • Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in Italy

Also in 22 other countries, 284 sites

  • BolognaHospital not named in the registryContact: Akero Site 0908Taking people
  • CataniaHospital not named in the registryContact: Akero Site 0914Taking people
  • FoggiaHospital not named in the registryContact: Akero Site 0909Taking people
  • MessinaHospital not named in the registryContact: Akero Site 0912Taking people
  • MilanHospital not named in the registryContact: Akero Site 0911Taking people
  • ModenaHospital not named in the registryContact: Akero Site 0906Taking people
  • NovaraHospital not named in the registryContact: Akero Site 0905Taking people
  • RomaHospital not named in the registryContact: Akero Site 0913Taking people
  • Rozzano, MilanHospital not named in the registryContact: Akero Site 0904Taking people
  • San Giovanni Rotondo, FoggiaHospital not named in the registryContact: Akero Site 0901Taking people
  • Torino, TurinHospital not named in the registryContact: Akero Site 0910Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • EFX 50 mgTreatment being tested

    Treatment: Efruxifermin

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests efruxifermin in adults with cirrhosis caused by fatty liver diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06528314, who can take part
Record updated
12 November 2026