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AZD2373-Arm 1

Phase 2

APOL1-Mediated Kidney Disease | Small molecule | Nephrology |AstraZeneca PLC|Last Updated: Oct 29, 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 Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06824987Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney DiseasePHASE2 RECRUITING 96 — — Mar 5, 2025Aug 30, 2027Oct 29, 202577 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Relative change in Urine Albumin-Creatinine Ratio (UACR)
From Baseline at Week 30

To assess the effect of AZD2373 versus placebo in reducing albuminuria

Secondary Endpoints
Relative change in Urine Albumin-Creatinine Ratio (UACR)
From Baseline at the End of Treatment (Until the last participant completes Week 30)
Relative change in Urine Protein-Creatinine Ratio (UPCR)
From Baseline at Week 30
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
From Baseline at Week 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo groupPLACEBO_COMPARATORParticipants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
AZD2373 - Arm 1EXPERIMENTALParticipants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
AZD2373 - Arm 2EXPERIMENTALParticipants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
Interventions
NameTypeDescription
AZD2373-Arm 1COMBINATION_PRODUCTAccessorized Pre-Filled Syringe (Solution for injection)
AZD2373-Arm 2COMBINATION_PRODUCTAccessorized Pre-Filled Syringe (Solution for injection)
PlaceboCOMBINATION_PRODUCTAccessorized Pre-Filled Syringe (Solution for injection).
APOL1 Genotyping Clinical Trial AssayDEVICEThe APOL1 Genotyping Clinical Trial Assay, an investigational use only qualitative Polymerase Chain Reaction invitro diagnostic assay, discriminates between the rs73885319 G1(S342G) and rs71785313 G2 genotypes within the APOL1 gene from DNA extracted from whole blood.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: * Age: Male and female participants aged 18 to 65 years, inclusive at the time of informed consent. * Participants who have high-risk APOL1 genotype (G1/G1; G1/G2; G2/G2). The screening period can be extended if there are delays related to the shipment, handling, or processing o...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06824987primaryCompletionDate: changed
LOWMay 24, 2026NCT06824987studyFirstPostDate: changed