Tests pegozafermin in adults with liver scarring from fatty liver disease
Tests pegozafermin against placebo in adults with compensated cirrhosis from MASH.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Key facts
- Where
- Amiens Cedex 1, Clichy, Dijon, Limoges Cedex 1, Lyon Cedex 04, Montpellier Cedex 5, Nice, Paris, Pessac, Strasbourg Cedex, Toulouse Cedex 3, Toulouse Cedex 9, Vandoeuvre Les Nancy, Vénissieux, and Villejuif, FranceSee 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 75 years old?
Source: NCT06419374, who can take part
Where in France
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
- Assistance Publique Hopitaux De ParisClichy, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranceTaking people
- Hospices Civils De LyonLyon Cedex 04, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranceTaking people
- Clinique PasteurToulouse Cedex 3, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranceTaking people
- Centre de Recherche Clinique Portes Du SudVénissieux, FranceTaking people
- Assistance Publique Hopitaux De ParisVillejuif, FranceTaking 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
- NCT06419374EU 2023-510395-31-00
- Record updated
- 23 October 2026
- Original description
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .Read full original descriptionShow less
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
Inclusion: Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF); Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors; Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening; Clinical diagnosis of cirrhosis based on the NIT algorithm.
Exclusion: Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening; Other protocol-defined inclusion and exclusion criteria may apply; Liver disorder other than MASH; Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus; ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L); History or evidence of hepatic decompensation; History or evidence of hepatocellular carcinoma.