ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Phase 3

Recruiting

• Conditions: Cardiovascular Risk; Acute Myocardial Infarction (AMI)
• Interventions: Drug: Placebo; Drug: Ziltivekimab

• Registration Number: NCT06118281
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Study Start: 2024-06-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-09-03
• Study Completion: 2026-09-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo ziltivekimab	Placebo	Participants 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.
Ziltivekimab	Ziltivekimab	Participants 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of CV death, non-fatal MI, non-fatal stroke	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as count of events.
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)	Measured in months.
Number of all-cause mortality, non-fatal MI, non-fatal stroke	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as count of events.
Time to first occurrence of non-fatal MI	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Time to first occurrence of MI (fatal and non-fatal)	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Time to first occurrence of non-fatal stroke	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Time to first occurrence of stroke (fatal and non-fatal)	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Time to first occurrence of a 3-component coronary MACE endpoint comprising:CV death, Non-fatal MI, Ischaemia-driven coronary revascularisation	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Time to first occurrence of a 5-component expanded MACE endpoint comprising: CV death, Non-fatal MI, Non-fatal stroke, Ischaemia-driven coronary revascularisation, Heart failure (HF) hospitalisation or urgent HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Number of CV death, non-fatal MI, non-fatal stroke, ischaemia-driven coronary revascularisation, or HF hospitalisation or urgent HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measired as count of events.
Time to first occurrence of a 3-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit, Outpatient HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Number of CV deaths, HF hospitalisation or urgent HF visits or outpatient HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in count of events.
Time to first occurrence of a 2-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as months.
Number of CV deaths, HF hospitalisation or urgent HF visits	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in count of events.
Time to first occurrence of a 2-component expanded HF endpoint comprising: HF hospitalisation or urgent HF visit, Outpatient HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as months.
Number of HF hospitalisation or urgent HF visit or outpatient HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as count of events.
Number of outpatient HF visit	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in count of events.
Time to occurrence of CV death	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as months.
Time to occurrence of all-cause death	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as months.
Time to first occurrence of 6-component vascular event endpoint: CV death, Non-fatal MI, Non-fatal stroke, Ischaemia-driven coronary revascularisation, Non-coronary revascularisation procedure, Any other non-coronary ischaemic event excluding stroke	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Number of CV death, non-fatal MI and non-fatal stroke, ischaemia-driven coronary revascularisation, non-coronary revascularisation procedure, or any other non-coronary ischaemic event excluding stroke	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as count of events.
Number of ischaemia-driven coronary revascularisation	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as count of events.
Time to first occurrence of ischaemia-driven coronary revascularisation or any non-coronary revascularisation	From randomisation (month 0) to end-of-study (up to 25 months)	Measured in months.
Number of ischaemia-driven coronary revascularisation or any non-coronary revascularisation	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as count of events.
Number of cardiovascular hospitalisations	From randomisation (month 0) to 12 months	Measured as count of events.
Number of hospitalisations with infection as primary cause or death due to infection	From randomisation (month 0) to end-of-study (up to 25 months)	Measured as count of events.
Change in high-sensitivity C-reactive protein (hs-CRP)	From randomisation (month 0) to 6 months	Measured as ratio to baseline.

Trial Locations

Locations (770)

Advanced Cardiovascular, LLC; 🇺🇸 Alexander City, Alabama, United States

Birmingham VA Medical Center; 🇺🇸 Birmingham, Alabama, United States

Grandview Medical Center; 🇺🇸 Birmingham, Alabama, United States

Eastern Shore Rsrch Inst, LLC; 🇺🇸 Fairhope, Alabama, United States

Heart Center Rsrch_Hunstville; 🇺🇸 Huntsville, Alabama, United States

Mobile Heart USA Health Cardiology Clinic; 🇺🇸 Mobile, Alabama, United States

Mercy Gilbert Medical Center; 🇺🇸 Gilbert, Arizona, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

Arkansas Cardiology Clinic; 🇺🇸 Little Rock, Arkansas, United States

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