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
- Angers, Clichy, Créteil, Le Chesnay, Lille, Limoges, Lyon, Marseille, Montpellier Cedex 5, Nice, Paris, Pessac, Strasbourg, Toulouse, and Vandœuvre-lès-Nancy, FranceSee the 15 sitesAlso in 22 other countries, 280 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 France
Also in 22 other countries, 280 sites
- Angers, Maine-et-LoireHospital not named in the registryContact: Akero Site 0602Taking people
- Clichy, Hauts-de-SeineHospital not named in the registryContact: Akero Site 0603Taking people
- Créteil, Val-De-MarneHospital not named in the registryContact: Akero Site 0614Taking people
- Le Chesnay, Île-de-France RegionHospital not named in the registryContact: Akero Site 0612Taking people
- Lille, Hauts-de-FranceHospital not named in the registryContact: Akero Site 0613Taking people
- Limoges, Haute-VienneHospital not named in the registryContact: Akero Site 0609Taking people
- Lyon, Auvergne-Rhône-AlpesHospital not named in the registryContact: Akero Site 0604Taking people
- Marseille, Provence-Alpes-Côte d'Azur RegionHospital not named in the registryContact: Akero Site 0601Taking people
- Montpellier Cedex 5, Provence-Alpes-Côte d'Azur RegionHospital not named in the registryContact: Akero Site 0608Taking people
- Nice, Alpes-MaritimesHospital not named in the registryContact: Akero Site 0606Taking people
- Paris, Île-de-France RegionHospital not named in the registryContact: Akero Site 0605Taking people
- Pessac, GirondeHospital not named in the registryContact: Akero Site 0615Taking people
- Strasbourg, Bas-RhinHospital not named in the registryContact: Akero Site 0607Taking people
- Toulouse, OccitanieHospital not named in the registryContact: Akero Site 0610Taking people
- Vandœuvre-lès-Nancy, LorraineHospital not named in the registryContact: Akero Site 0611Taking 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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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