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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Pegozafermin (biological), Placebo (other)
How long the study runs: Study runs about 59 months (dates as stated)
About the drug or intervention: Pegozafermin — biological: Subcutaneous injection · Placebo — other: Subcutaneous injection
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years to 80 Years
Who: All
Number of participants: 1,350
Started: 2024-03-13
Last checked: 2026-10

Plain English Summary

What is this study?

• Testing a new treatment for metabolic dysfunction-associated steatotic liver disease (mash) / nonalcoholic steatohepatitis (nash) with fibrosis
• Phase3 - 1,350 participants
• 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

Who can take part?

• Ages 18 Years to 80 Years
• Diagnosed with metabolic dysfunction-associated steatotic liver disease (mash) / nonalcoholic steatohepatitis (nash) with fibrosis

Where?

• High Wycombe - 89bio Clinical Study Site
• Bristol - 89bio Clinical Study Site
• Glasgow - 89bio Clinical Study Site
• Hull - 89bio Clinical Study Site
• +13 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years - 80 Years
Who can join: All genders

What the study is looking for

✓Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the agreement to take part form...
✓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

✗Chronic liver diseases other than MASH
✗Evidence of cirrhosis on screening liver biopsy
✗Have type 1 diabetes or poorly controlled type 2 diabetes
✗Alanine aminotransferase (liver enzymes) or aspartate aminotransferase (liver enzymes) ≥250 units per liter (U/L)
✗Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at...

See the full criteria

Key Inclusion Criteria: * 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). Key Exclusion Criteria: * Chronic liver diseases other than MASH * Evidence of cirrhosis on screening liver biopsy * Have type 1 diabetes or poorly controlled type 2 diabetes * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L) * 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.

Where Is This Study? (17 UK sites)

89bio Clinical Study Site

High Wycombe HP11 2QW, United Kingdom

Recruiting

89bio Clinical Study Site

Bristol BS6 6LT, United Kingdom

Recruiting

89bio Clinical Study Site

Glasgow G514TY, United Kingdom

Recruiting

89bio Clinical Study Site

Hull HU3 2JZ, United Kingdom

WITHDRAWN

89bio Clinical Study Site

London E13 8SL, United Kingdom

Recruiting

89bio Clinical Study Site

London E1, United Kingdom

Recruiting

89bio Clinical Study Site

London NW32QG, United Kingdom

Recruiting

89bio Clinical Study Site

London SE5 9RS, United Kingdom

Recruiting

89bio Clinical Study Site

London W2 1NY, United Kingdom

Recruiting

89bio Clinical Study Site

Oxford OX3 9DU, United Kingdom

Recruiting

89bio Clinical Study Site

Portsmouth PO6 3LY, United Kingdom

Recruiting

89bio Clinical Study Site

Preston PR2 9QB, United Kingdom

Recruiting

89bio Clinical Study Site

Southampton SO16 6YD, United Kingdom

Recruiting

89bio Clinical Study Site

Stockton TS19, United Kingdom

Recruiting

89bio Clinical Study Site

Sunderland SR4 7TP, United Kingdom

Recruiting

89bio Clinical Study Site

Swansea SA6, United Kingdom

Recruiting

89bio Clinical Study Site

York YO24 4LJ, United Kingdom

Recruiting

How to Get in Touch

Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10