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Ziltivekimab B

Phase 3

Cardiovascular Risk | Small molecule | Immunology |Novo Nordisk A/S|Last Updated: Apr 13, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment6,200
FDA Designations
No designations recorded
Clinical trial landscape

Ziltivekimab B · 2 trials · 4 indications

Phase 3 1Phase 1 1
NCT05021835ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and InflammationCardiovascular Risk
ACTIVE NOT_RECRUITING6,200 Analytics
PHASE3ACTIVE NOT_RECRUITING
ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
Cardiovascular Risk
NCT050218356,200
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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

AUC0-inf, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours and extrapolated to infinity after a single dose
From day 1 (pre-dose) to day 183 after a single dose

Measured in day\*microgram per milliliter (day\*μg/mL).

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.
Ziltivekimab B (manual syringe)EXPERIMENTALParticipants will receive a single subcutaneous (s.c.) injection of 15 milligram (mg) ziltivekimab B (15 milligrams per milliliter \[mg/mL\]) by single-use pre-filled manual syringe on Day 1.
Ziltivekimab D (manual syringe)EXPERIMENTALParticipants will receive a single s.c. injection of 15 mg ziltivekimab D (15 mg/mL) by single-use pre-filled manual syringe on Day 1.
Ziltivekimab C (pen-injector)EXPERIMENTALParticipants will receive a single s.c. injection of 15 mg ziltivekimab C (30 mg/mL) by single-use pre-filled syringe assembled into a shield-activated pen-injector on Day 1.
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.
Ziltivekimab DDRUGParticipants will receive a single s.c. injection of 15 mg ziltivekimab D (15 mg/mL) by single-use pre-filled manual syringe on Day 1.
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Eligibility Criteria
Age Range18 Years to 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 33 trials (matched to "Cardiovascular Risk")
CompanyTickerTrialsLead PhaseDrugs
BridgeBio Pharma, Inc.BBIO2PHASE3Acoramidis
Kiniksa Pharmaceuticals International, plc Class AKNSA1PHASE2KPL-387
AstraZeneca PLCAZN3PHASE1AZD1705
Abbott LaboratoriesABT5N/AUndisclosed
Edwards Lifesciences CorporationEW2N/AUndisclosed
Teleflex IncorporatedTFX1N/AUndisclosed
Boston Scientific CorporationBSX1 - Undisclosed
HeartFlow, Inc.HTFL2 - Undisclosed
Rocket Pharmaceuticals, Inc.RCKT2 - Undisclosed
CRISPR Therapeutics AGCRSP1PHASE1CTX310
GE Healthcare Technologies Inc.GEHC1N/AUndisclosed
Harvard Bioscience, Inc.HBIO2 - Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05021835primaryCompletionDate: changed
LOWMay 24, 2026NCT05021835studyFirstPostDate: changed