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AZD4831

Phase 2

Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Jul 9, 2025

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 Enrollment112
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05638737A Study in Participants With Non-cirrhotic NASH With FibrosisPHASE2 COMPLETED 112Oct 26, 2022Apr 4, 2024Jul 9, 202565 United States, Argentina +7
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Study Endpoints
Primary Endpoints
Relative to Baseline Alanine Aminotransferase (ALT)
Measurements on Baseline, Week 2, Week 4, Week 8, Week 12 and Week 16. Change reported from Baseline to Week 12.

ALT at 12 weeks relative to baseline. ALT is measured in Units per litre (U/L)

Secondary Endpoints
Relative to Baseline Pro-C3
Measurements on Baseline, Week 4 and Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD4831EXPERIMENTALAZD4831
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
AZD4831DRUGAZD4831
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: 1. Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent. 2. Histological confirmed NASH per Clinical Research Network (CRN) criteria as diagnosed by liver biopsy (within 12 months prior screening, participants without historical biopsy should...

Countries:United StatesArgentinaDenmarkItalyMexicoNorwayPortugalSpainSweden
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