Tests pegozafermin against placebo in liver scarring from fatty liver disease
Tests pegozafermin doses versus placebo in adults with MASH and liver scarring.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Key facts
- Where
- Brno, Ostrava, and Plzen 3, CzechiaSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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 with MASH (a fatty liver disease with inflammation) and liver scarring of stage F2 or F3, confirmed by a liver biopsy.
- Age
- 18 to 80 years
- Sex
- Men and women; women cannot be pregnant
- Disease stage
- MASH confirmed by biopsy, with liver scarring (fibrosis) of stage F2 or F3
- Earlier treatment
- People taking vitamin E (more than 400 IU a day) or pioglitazone must have been on a stable dose for at least 6 months before screening
- Biomarker or test result
- Body mass index (BMI) at screening of 25.0 kg/m² or more (23 kg/m² or more for Asian participants)
Main reasons for not taking part
- Chronic liver disease other than MASH
- Signs of cirrhosis on the screening liver biopsy
- Type 1 diabetes or poorly controlled type 2 diabetes
- ALT or AST of 250 U/L or more
Read by machine on 9 November 2026.
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: NCT06318169, who can take part
Where in Czechia
- Fakultni nemocnice BrnoBrno, CzechiaTaking people
- Fakultni nemocnice OstravaOstrava, CzechiaTaking people
- Research Site s.r.o.Plzen 3, CzechiaTaking 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
- Hoffmann-La Roche
- Trial code
- NCT06318169EU 2023-509912-27-00
- Record updated
- 23 October 2026
- Original description
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.Read full original descriptionShow less
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Inclusion: Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF); Biopsy-confirmed MASH with fibrosis stage F2 or F3; Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).
Exclusion: Participants taking vitamin E (>400 international units [IU]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening; Other inclusion and exclusion criteria may apply; Chronic liver diseases other than MASH; Have type 1 diabetes or poorly controlled type 2 diabetes; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L); Evidence of cirrhosis on screening liver biopsy.