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Pegozafermin

Phase 3

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis | Monoclonal antibody | Infectious Disease |89bio, Inc.|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment762
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06419374A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASHPHASE3 RECRUITING 762 — — May 24, 2024Aug 1, 2031Jun 4, 2026303 United States, Argentina +22
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Study Endpoints
Primary Endpoints
Proportion of Participants Achieving Fibrosis Regression
Baseline 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 Events
Baseline up to 5 years
Secondary Endpoints
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Baseline, up to Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level
Baseline, up to Month 60
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)
Baseline, up to Month 60
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PegozaferminEXPERIMENTAL -
PlaceboPLACEBO_COMPARATORMatched placebo
Interventions
NameTypeDescription
PegozaferminBIOLOGICALSubcutaneous injection
PlaceboDRUGSubcutaneous injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites303

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-confirme...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaFranceGermanyHong KongHungaryIndiaIsraelItalyMexicoNetherlandsPolandPuerto RicoSingaporeSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT06419374lastUpdatePostDate: changed
LOWJun 4, 2026NCT06419374lastUpdatePostDate: changed
LOWJun 4, 2026NCT06419374lastUpdatePostDate: changed
LOWJun 4, 2026NCT06419374lastUpdatePostDate: changed
LOWMay 26, 2026NCT06419374primaryCompletionDate: changed
LOWMay 24, 2026NCT06419374studyFirstPostDate: changed