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Ziltivekimab

Phase 3

Cardiovascular Risk | Small molecule | Cardiovascular |Novo Nordisk A/S|Last Updated: Apr 14, 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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06118281ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart AttackPHASE3 RECRUITING 10,000Jun 25, 2024Dec 14, 2026Apr 14, 2026970 United States, Argentina +22
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Study Endpoints
Primary Endpoints
Time to first occurrence of a 3-component major adverse cardiovascular event (MACE) endpoint comprising: Cardiovascular (CV) death, Non-fatal myocardial infarction (MI), Non-fatal stroke
From randomisation (month 0) to end-of-study (up to 25 months)

Measured in months.

Secondary Endpoints
Number of CV death, non-fatal MI, non-fatal stroke
From randomisation (month 0) to end-of-study (up to 25 months)
Time to first occurrence of a composite MACE endpoint consisting of: All-cause mortality, Non-fatal MI, Non-fatal stroke
From randomisation (month 0) to end-of-study (up to 25 months)
Number of all-cause mortality, non-fatal MI, non-fatal stroke
From randomisation (month 0) to end-of-study (up to 25 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZiltivekimabEXPERIMENTALParticipants will receive an initial loading dose of ziltivekimab Dose 1 subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for ST-elevation myocardial infarction (STEMI) and within 48 hours of hospitalisation for non-ST-elevation myocardial infarction (NSTEMI), followed by ziltivekimab Dose 2 s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care.
Placebo ziltivekimabEXPERIMENTALParticipants will receive placebo matched to ziltivekimab at an initial loading dose subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for STEMI and latest within 48 hours of hospitalisation for NSTEMI, followed by placebo matched to ziltivekimab s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care.
Interventions
NameTypeDescription
ZiltivekimabDRUGZiltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly.
PlaceboDRUGPlacebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites970

Key inclusion: * Age 18 years or above at the time of signing the informed consent. * Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities. * ST-segment...

Countries:United StatesArgentinaAustraliaBrazilBulgariaCanadaChinaCzechiaDenmarkFranceGermanyGreeceIndiaIsraelItalyJapanMalaysiaMexicoNetherlandsPolandSouth KoreaSpainTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06118281primaryCompletionDate: changed
LOWMay 24, 2026NCT06118281studyFirstPostDate: changed