Tests efruxifermin in adults with liver scarring from fatty liver disease
Tests efruxifermin against a placebo in adults with fatty liver disease and mild liver scarring.
Plain-language title generated from the registry record
Registry title: A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Key facts
- Where
- Adelaide, Broadmeadow, Caulfield South, Coffs Harbour, Epping, Frankston, Heidelberg, Kogarah, Liverpool, Melbourne, Murdoch, Nedlands, Penrith, Perth, and Westmead, AustraliaSee the 15 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT06215716, who can take part
Where in Australia
- AdelaideAdelaide, AustraliaTaking people
- BroadmeadowBroadmeadow, AustraliaTaking people
- Caulfield SouthCaulfield South, AustraliaTaking people
- Coffs HarbourCoffs Harbour, AustraliaTaking people
- EppingEpping, AustraliaTaking people
- FrankstonFrankston, AustraliaTaking people
- HeidelbergHeidelberg, AustraliaTaking people
- KogarahKogarah, AustraliaTaking people
- LiverpoolLiverpool, AustraliaTaking people
- MelbourneMelbourne, AustraliaTaking people
- MurdochMurdoch, AustraliaTaking people
- NedlandsNedlands, AustraliaTaking people
- PenrithPenrith, AustraliaTaking people
- PerthPerth, AustraliaTaking people
- WestmeadWestmead, AustraliaTaking people
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?
Trial details
- Who runs it
- Akero Therapeutics, Inc
- Trial code
- NCT06215716
- Record updated
- 6 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
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.
Inclusion: Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit; Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes; Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:; Steatosis (scored 0 to 3),; Ballooning degeneration (scored 0 to 2), and; Lobular inflammation (scored 0 to 3); Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.
Exclusion: Type 1 or uncontrolled Type 2 diabetes; Other inclusion and exclusion criteria may apply; Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results; Presence of cirrhosis on liver biopsy (fibrosis stage 4).