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Taking people in ItalyPhase 3

Tests pegozafermin in adults with liver scarring from fatty liver disease

Tests pegozafermin against placebo in adults with compensated cirrhosis from MASH.

Key facts

Who runs it
Hoffmann-La Roche
Where
Bergamo, Foggia, Milan, Novara, Palermo, Rome, Rozzano, and Turin, ItalySee the 10 sitesAlso in 24 other countries, 267 sites
Trial code
Registry title
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Status
Recruiting
Phase
Phase 3
People taking part
1,800 people, planned
Started
24 May 2024
Expected to end
31 Aug 2031
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Pegozafermin
  • Placebo
Record updated
23 October 2026

Who can take part

AI summary

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 aged 18 to 75 with compensated cirrhosis (scarred liver that still works) caused by MASH (fatty liver disease linked to metabolism). The cirrhosis and MASH must be confirmed.

Age
18 to 75 years
Sex
All sexes. Women must not be pregnant.
Disease stage
Compensated cirrhosis due to MASH, shown by a liver biopsy (historical or at screening) and by a clinical test-based (NIT) diagnosis of cirrhosis.
Earlier treatment
People taking vitamin E (more than 400 IU per day) must have been on a stable dose for at least 6 months before screening.
Biomarker or test result
Type 2 diabetes diagnosed at least 3 months before screening, or at least 2 metabolic risk factors.

Main reasons for not taking part

  • A liver disease other than MASH
  • Past or current signs of hepatic decompensation (the liver no longer coping)
  • Past or current liver cancer (hepatocellular carcinoma)
  • Type 1 diabetes or poorly controlled type 2 diabetes
  • ALT or AST of 250 U/L or higher

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Italy

Also in 24 other countries, 267 sites

  • 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

About the trial

What the trial wants to find out

The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .

The 2 groups in the trial

  • PegozaferminTreatment being tested
  • PlaceboPlacebo, for comparison

    Matched placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests pegozafermin in adults with liver scarring from fatty liver diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06419374, who can take part
Record updated
23 October 2026