protocolSection identificationModule nctId: NCT06318169, orgStudyIdInfo id: BIO89-100-131, briefTitle: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: 89bio, Inc., class: INDUSTRY, descriptionModule briefSummary: The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\])., conditionsModule conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Pegozafermin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52, primaryOutcomes measure: Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52, secondaryOutcomes measure: Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52, secondaryOutcomes measure: Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36, secondaryOutcomes measure: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72211-3859, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 34.74648, lon: -92.28959, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Ocala, state: Florida, zip: 34471, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 29.1872, lon: -82.14009, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Hermitage, state: Tennessee, zip: 37076, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 36.19617, lon: -86.6225, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Wichita Falls, state: Texas, zip: 76301, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 33.91371, lon: -98.49339, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Richmond, state: Virginia, zip: 23226-1925, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False