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
- Graz, Innsbruck, Klagenfurt Am Woerthersee, St. Poelten, and Wels, AustriaSee the 5 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: NCT06318169, who can take part
Where in Austria
- Medical University of GrazGraz, AustriaTaking people
- Medizinische Universitaet InnsbruckInnsbruck, AustriaTaking people
- Landeskrankenanstalten-Betriebsgesellschaft KabegKlagenfurt Am Woerthersee, AustriaTaking people
- Noe LGA Gesundheit Region Mitte GmbHSt. Poelten, AustriaTaking people
- Klinikum Wels-Grieskirchen GmbHWels, AustriaTaking 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.