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Taking people in CzechiaPhase 3

Tests pegozafermin against placebo in liver scarring from fatty liver disease

Tests pegozafermin doses versus placebo in adults with MASH and liver scarring.

Key facts

Who runs it
Hoffmann-La Roche
Where
Brno, Ostrava, and Plzen 3, CzechiaSee the 3 sitesAlso in 26 other countries, 313 sites
Trial code
Registry title
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Status
Recruiting
Phase
Phase 3
People taking part
1,350 people, planned
Started
13 Mar 2024
Expected to end
Feb 2029
Type of study
Interventional, 3 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 with MASH (a fatty liver disease with inflammation) and liver scarring of stage F2 or F3, confirmed by a liver biopsy.

Age
18 to 80 years
Sex
Men and women; women cannot be pregnant
Disease stage
MASH confirmed by biopsy, with liver scarring (fibrosis) of stage F2 or F3
Earlier treatment
People taking vitamin E (more than 400 IU a day) or pioglitazone must have been on a stable dose for at least 6 months before screening
Biomarker or test result
Body mass index (BMI) at screening of 25.0 kg/m² or more (23 kg/m² or more for Asian participants)

Main reasons for not taking part

  • Chronic liver disease other than MASH
  • Signs of cirrhosis on the screening liver biopsy
  • Type 1 diabetes or poorly controlled type 2 diabetes
  • ALT or AST of 250 U/L or more

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

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 80 years old?

Where in Czechia

Also in 26 other countries, 313 sites

  • Fakultni nemocnice BrnoBrno, CzechiaTaking people
  • Fakultni nemocnice OstravaOstrava, CzechiaTaking people
  • Research Site s.r.o.Plzen 3, CzechiaTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Pegozafermin Regimen 1Treatment being tested

    Treatment: Pegozafermin

  • Pegozafermin Regimen 2Treatment being tested

    Treatment: Pegozafermin

  • PlaceboPlacebo, for comparison

    Matched Placebo will be administered in Regimens 1 and 2.

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 Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Plain-language title
Tests pegozafermin against placebo in 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 NCT06318169, who can take part
Record updated
23 October 2026