Back to search results

A Study of Pegozafermin for MASH with Compensated Cirrhosis

This study is testing a drug called pegozafermin to see if it's safe and effective for people with compensated cirrhosis due to MASH (Metabolic Dysfunction-Associated Steatohepatitis), also known as NASH. MASH is a liver disease where fat builds up in the liver, causing inflammation and damage. You might be able to join if you are 18 to 75 years old, have type 2 diabetes or at least two other metabolic risk factors, and have MASH with compensated cirrhosis confirmed by a liver biopsy. The study will look at whether pegozafermin can help reduce liver scarring (fibrosis) and prevent the disease from getting worse. The current recruitment status is unclear.

Study design
This study is an interventional study planning to enroll 762 participants. Participants will receive either pegozafermin or a placebo (an inactive substance) through subcutaneous injections.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for fibrosis regression from baseline through Month 24, and for disease progression for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06419374

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

Recruiting
PHASE3Ages 18–75InterventionalTreatment
89bio, Inc.
~762 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:PegozaferminPlacebo

At a glance

Recruiting sites
297 of 326 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Achieving Fibrosis Regression
Measured over Baseline through Month 24
+1 more outcome measured

Conditions

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

Explore related trials

Nonalcoholic Steatohepatitis

NCT06419374

Where you'd take part

This study runs at 326 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • 89bio Clinical Study Site

    Birmingham, Alabamano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Homewood, Alabamano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Chandler, Arizonano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Peoria, Arizonano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Phoenix, Arizonano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Sun City, Arizonano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Tucson, Arizonano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Tucson, Arizonano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: BIO89-100-132 ENLIGHTEN clinical trial / No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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.
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).

Exclusion

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.

What this trial measures

  • Proportion of Participants Achieving Fibrosis RegressionBaseline through Month 24

    Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.

  • Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical EventsBaseline up to 5 years