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ENLIGHTEN-Fibrosis Study for MASH and Fibrosis

This study, called ENLIGHTEN-Fibrosis, is looking at a treatment called pegozafermin for people with MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) and liver scarring (fibrosis) at stages F2 or F3. Researchers want to see how well pegozafermin works and if it's safe compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 80 years old, have MASH with F2 or F3 fibrosis confirmed by a liver biopsy, and meet certain BMI requirements. The study will measure success by looking at whether your liver fibrosis improves without your MASH getting worse, or if your MASH resolves without your fibrosis getting worse, both at 52 weeks. The current status of this study is unclear.

Study design
This is an interventional study comparing two doses of pegozafermin to a placebo. It plans to enroll 1350 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to track the time to the first occurrence of disease progression.

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

NCT06318169

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

Recruiting
PHASE3Ages 18–80InterventionalTreatment
89bio, Inc.
~1,350 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:PegozaferminPlacebo

At a glance

Recruiting sites
338 of 367 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52
Measured over Week 52
+2 more outcomes measured

Conditions

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

Explore related trials

Nonalcoholic Steatohepatitis

NCT06318169

Where you'd take part

This study runs at 367 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

    Chandler, Arizonano site contact published

    Recruiting

  • 89bio Clinical Study Site

    Glendale, 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

  • 89bio Clinical Study Site

    Little Rock, Arkansasno site contact published

    Recruiting

  • 89bio Clinical Study Site

    North Little Rock, Arkansasno 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 · 89bio, Inc.

Who to contact

Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Eligibility criteria

Inclusion

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).

Exclusion

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

What this trial measures

  • Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52Week 52

    Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis

  • Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52Week 52

    Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.

  • Time to First Occurrence of Disease ProgressionUp to 5 years

    Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events