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
- Bergamo, Foggia, Milan, Novara, Palermo, Rome, Rozzano, and Turin, ItalySee the 10 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 Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking 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.