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Ziltivekimab B

Phase 3

Cardiovascular Risk | Monoclonal antibody | Immunology |Novo Nordisk A/S|Trials Updated: Sep 28, 2026

Ziltivekimab B development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Aug 2021

Ziltivekimab B target and mechanism

Molecular targetIL6
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment6,385

FDA Designations

No designations recorded

Ziltivekimab B clinical trials

Ziltivekimab B · 1 trial · 3 indications

Phase 3 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
COMPLETED6,385 Analytics
PHASE3COMPLETED
ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
Cardiovascular RiskUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites1073

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 38 trials (matched to "Cardiovascular Risk")

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Recent Changes (Last 90 Days)

MEDIUMAug 28, 2026NCT05021835TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT05021835TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT05021835TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT05021835TRIAL_REMOVED: changed
HIGHJul 28, 2026NCT05021835Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 28, 2026NCT05021835Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about Ziltivekimab B

What is ziltivekimab B?

Ziltivekimab B is an investigational monoclonal antibody developed by Novo Nordisk A/S for cardiovascular risk. It is being studied in people with cardiovascular disease, chronic kidney disease and inflammation. It is a Phase 3 candidate and has not been approved for marketing.

What is ziltivekimab B used for?

Ziltivekimab B is being developed for cardiovascular risk in patients who also have chronic kidney disease and inflammation. The Phase 3 ZEUS study enrolled adults with these conditions. It is investigational, so it is not yet an approved treatment for any indication.

What does ziltivekimab B target?

Ziltivekimab B targets interleukin-6, or IL6. It is an IL6 inhibitor and a monoclonal antibody, meaning it is designed to bind and block the activity of this inflammatory cytokine. Targeting IL6 is intended to reduce the inflammation that accompanies cardiovascular and kidney disease.

Who makes ziltivekimab B?

Ziltivekimab B is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program studying the drug in cardiovascular risk, chronic kidney disease and inflammation.

What phase is ziltivekimab B in?

Ziltivekimab B is in Phase 3 development. Its Phase 3 trial, ZEUS, has completed. The drug remains investigational and has not been approved by the FDA or any other regulator based on the information available.

What clinical trials is ziltivekimab B in?

Ziltivekimab B has been studied in the Phase 3 ZEUS trial, registered as NCT05021835. ZEUS was a randomized, double-blind, placebo-controlled study that enrolled 6,385 adults aged 18 and older across many countries. It examined ziltivekimab B versus placebo in people with cardiovascular disease, chronic kidney disease and inflammation, and it has completed.