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AZD2693

Phase 2

Nonalcoholic Steatohepatitis | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Oct 28, 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 Enrollment220
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05809934A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With FibrosisPHASE2 COMPLETED 220 — — Mar 15, 2023Sep 29, 2025Oct 28, 2025164 United States, Argentina +20
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Study Endpoints
Primary Endpoints
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
after 52 weeks

To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks

Secondary Endpoints
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment
after 52 weeks
Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment
after 52 weeks
Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment
after 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD2693 dose 1EXPERIMENTALParticipants will receive AZD2693 dose 1
AZD2693 dose 2EXPERIMENTALParticipants will receive AZD2693 dose 2
PlaceboPLACEBO_COMPARATORParticipants in this arm will receive placebo
Interventions
NameTypeDescription
AZD2693DRUGAZD2693 solution SC once per month
PlaceboOTHERSodium chloride 0.9% solution SC once per month
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites164

Key Inclusion Criteria : Participants are eligible to be included in the study only if all the following criteria apply: Age 1. Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Participants wh...

Countries:United StatesArgentinaBrazilChileChinaColombiaGermanyHong KongIndiaItalyJapanMalaysiaMexicoPeruPhilippinesSingaporeSouth KoreaSpainTaiwanThailandTurkey (Türkiye)Vietnam
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