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Ziltivekimab B

Phase 3

Cardiovascular Risk | Small molecule | Nephrology |Novo Nordisk A/S|Last Updated: Apr 13, 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 Enrollment6,200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05021835ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and InflammationPHASE3 ACTIVE NOT_RECRUITING 6,200 — — Aug 30, 2021Jun 9, 2026Apr 13, 20261065 United States, Argentina +36
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Study Endpoints
Primary Endpoints
Time to first occurrence of 3-point Major Adverse Cardiovascular Event (MACE), a composite endpoint consisting of: Cardiovascular (CV) death, non-fatal Myocardial Infarction (MI) and non-fatal stroke
From randomisation (month 0) to end-of-study (up to 48 months)

Months

Secondary Endpoints
Time to first occurrence of expanded MACE, a composite endpoint consisting of: CV death, non-fatal MI, non-fatal stroke and hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation
From randomisation (month 0) to end-of-study (up to 48 months)
Number of heart failure hospitalisations or urgent heart failure visits or CV deaths
From randomisation (month 0) to end-of-study (up to 48 months)
Time to first occurrence of a composite kidney endpoint consisting of: CV death, onset of persistent atleast 40 percent (%) reduction in eGFR (CKD-epidemiology collaboration [CKD-EPI]) compared with baseline, kidney failure
From randomisation (month 0) to end-of-study (up to 48 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZiltivekimabEXPERIMENTALParticipants will receive Ziltivekimab B or Ziltivekimab C subcutaneously once monthly for up to 4 years.
PlaceboPLACEBO_COMPARATORParticipants will receive either placebo (Ziltivekimab B) or placebo (Ziltivekimab C) subcutaneously once monthly for up to 4 years.
Interventions
NameTypeDescription
Ziltivekimab BDRUGAdministered subcutaneously (s.c., under skin) once-monthly added to standard of care.
Ziltivekimab CDRUGAdministered subcutaneously (s.c., under skin) once-monthly added to standard of care.
Placebo (Ziltivekimab B)DRUGAdministered subcutaneously (s.c., under skin) once-monthly added to standard of care.
Placebo (Ziltivekimab C)DRUGAdministered subcutaneously (s.c., under skin) once-monthly added to standard of care.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1065

Inclusion Criteria: * Chronic kidney disease defined by one of the below: 1. Estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 15 and below 60 mL/min/1.73 m\^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation) 2. Urinary albumi...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaChinaCroatiaCzechiaDenmarkGermanyGreeceHungaryIndiaIsraelItalyJapanLatviaLithuaniaMalaysiaMexicoNetherlandsPolandPortugalRomaniaRussiaSerbiaSlovakiaSouth AfricaSouth KoreaSpainSwedenTaiwanThailandTurkey (Türkiye)UkraineUnited Kingdom
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Competitive Landscape -Cardiovascular Disorders 34 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN4PHASE3Ravulizumab, AZD1705
BridgeBio Pharma, Inc.BBIO2PHASE3Acoramidis
Kiniksa Pharmaceuticals International, plc Class AKNSA1PHASE2KPL-387
Abbott LaboratoriesABT5NAUndisclosed
Edwards Lifesciences CorporationEW2NAUndisclosed
Teleflex IncorporatedTFX1NAUndisclosed
Boston Scientific CorporationBSX1 — Undisclosed
HeartFlow, Inc.HTFL2 — Rosuvastatin
Rocket Pharmaceuticals, Inc.RCKT2 — Undisclosed
CRISPR Therapeutics AGCRSP1PHASE1CTX310
GE Healthcare Technologies Inc.GEHC1NAUndisclosed
Harvard Bioscience, Inc.HBIO2 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05021835primaryCompletionDate: changed
LOWMay 24, 2026NCT05021835studyFirstPostDate: changed