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A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

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 (drug)
How long the study runs: Study runs about 87 months (dates as stated)
About the drug or intervention: Pegozafermin — biological: Subcutaneous injection · Placebo — drug: Subcutaneous injection
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years to 75 Years
Who: All
Number of participants: 762
Started: 2024-05-24
Last checked: 2026-10

Plain English Summary

What is this study?

• Testing a new treatment for metabolic dysfunction-associated steatohepatitis (mash) / nonalcoholic steatohepatitis (nash) with compensated cirrhosis
• Phase3 - 762 participants
• The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\])

Who can take part?

• Ages 18 Years to 75 Years
• Diagnosed with metabolic dysfunction-associated steatohepatitis (mash) / nonalcoholic steatohepatitis (nash) with compensated cirrhosis

Where?

• Aberdeen - 89bio Clinical Study Site
• Bristol - 89bio Clinical Study Site
• Leeds - 89bio Clinical Study Site
• London - 89bio Clinical Study Site
• +8 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 pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

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 - 75 Years
Who can join: All genders

Treatment history

Treatments you must have had:

✓ type 2 diabetes mellitus diagnosed at least 3 months

What the study is looking for

✓Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the agreement to take part form...
✓Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic...
✓Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
✓Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).

Who cannot take part

✗Liver disorder other than MASH.
✗History or evidence of liver decompensation.
✗History or evidence of hepatocellular carcinoma.
✗Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
✗liver enzymes or aspartate aminotransferase (liver enzymes) ≥250 units per liter (U/L).

See the full criteria

Key Inclusion Criteria: * 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. * Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). Key Exclusion Criteria: * Liver disorder other than MASH. * History or evidence of hepatic decompensation. * History or evidence of hepatocellular carcinoma. * Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. * ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L). * 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.

Where Is This Study? (12 UK sites)

89bio Clinical Study Site

Aberdeen AB25 2ZN, United Kingdom

Recruiting

89bio Clinical Study Site

Bristol BS10 5NB, United Kingdom

Recruiting

89bio Clinical Study Site

Leeds LS9 7TF, United Kingdom

Recruiting

89bio Clinical Study Site

London E1 1BB, United Kingdom

Recruiting

89bio Clinical Study Site

London NW3 2QG, 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

Plymouth PL6 8DH, United Kingdom

Recruiting

89bio Clinical Study Site

Port Talbot SA12 7BR, United Kingdom

Recruiting

89bio Clinical Study Site

Portsmouth P06 3LY, United Kingdom

Recruiting

89bio Clinical Study Site

Southampton SO16 6YD, United Kingdom

Recruiting

How to Get in Touch

Reference Study ID Number: BIO89-100-132 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