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
- Tbilisi, GeorgiaSee the site
- 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 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
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 75 years old?
Source: NCT06419374, who can take part
Where in Georgia
- TbilisiTbilisi, GeorgiaTaking 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.