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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Novo Nordisk A/S

NCT ID: NCT06118281

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ziltivekimab (drug), Placebo (drug)
How long the study runs
Study runs about 31 months (dates as stated)
About the drug or intervention
Ziltivekimab — drug: Ziltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly. · Placebo — drug: Placebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
10,000
Started
2024-06-25
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiovascular risk
  • • Phase3 - 10,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with cardiovascular risk

Where?

  • • Truro - Royal Cornwall Hospital (Treliske)
  • • Torquay - Torbay Hospital - Cardiology
  • • Bournemouth - Royal Bournemouth Hospital - Cardiology
  • • Ashford - William Harvey Hospital
  • • +23 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Cardiovascular RiskAcute Myocardial Infarction (AMI)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFRof a positiveconfirmed positive

What the study is looking for

  • ✓Key inclusion:
  • ✓Age 18 years or above at the time of signing the agreement to take part.
  • ✓Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive...
  • ✓Key exclusion:
  • ✓Use of fibrinolytic therapy for treatment of the current AMI.
See the full criteria
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 elevation myocardial infarction (STEMI) with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation, at the investigator's discretion. b) Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads greater than or equal 0.25 (millivolt) mV in men less than 40 years, greater than or equal 0.2 mV in men greater than or equal 40 years, or greater than or equal 0.15 mV in women in leads V2-V3; and/or greater than or equal 0.1 mV in all other leads. OR * Non-ST-segment myocardial infarction with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation, at the investigator's discretion. b) Rise and/or fall in car-diac troponin I or T with at least one value above the 99th percentile upper reference limit. * Possibility for both randomisation and administration of the loading dose of study intervention as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 72 hours of hospitalisation (time 0) for NSTEMI. * Presence of at least one of the following criteria confirmed based on the participant's medical records and/or medical history interview: a) Any prior MI. b) Prior coronary revascularisation. c) Diabetes mellitus treated with ongoing glucose-lowering agent(s). d)Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than or equal to 15 and less than 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2). e) Prior ischaemic stroke. f) Known carotid disease or peripheral artery disease in the lower extremities. g) Multivessel coronary artery disease (current/prior). h) For STEMI patients only: anterior MI at index acute myocardial infarction (AMI) Key exclusion: * Use of fibrinolytic therapy for treatment of the current AMI. * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV. * Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV. b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg)). * Severe kidney impairment defined as any of the following: a) eGFR less than 15 mililitre per minute per 1.73 m\^2. b) Chronic haemodialysis or peritoneal dialysis. * Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN). * Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation). b) Previously known or current ascites (clinical eval-uation). c) Jaundice (clinical evaluation). d) Previous oesophageal/gastric variceal bleeding. c) Known hepatic cirrhosis. * Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery (CABG)), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG). Deferred (staged)percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed. * Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. * Known (acute or chronic) hepatitis B or hepatitis C. * History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation. b) Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2).

Where Is This Study? (27 UK sites)

Royal Cornwall Hospital (Treliske)

Truro TR1 3HD, United Kingdom

Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

Torbay Hospital - Cardiology

Torquay TQ2 7AA, United Kingdom

Royal Bournemouth Hospital - Cardiology

Bournemouth BH7 6JH, United Kingdom

Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

William Harvey Hospital

Ashford TN24 0LZ, United Kingdom

Blackpool Victoria Hospital

Blackpool FY3 8NR, United Kingdom

Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Harefield Hospital

Harefield UB9 6JH, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Royal Brompton and Harefield Hospitals

Harefield UB9 6JH, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Royal Infirmary of Edinburgh - Cardiology

Edinburgh EH16 4SA, United Kingdom

Golden Jubilee University National Hospital

Glasgow G81 4SA, United Kingdom

Kettering General Hospital

Kettering NN16 8UZ, United Kingdom

Hospital R&D contact (matched)

Research and Development

kgh-tr.researchkgh@nhs.net01536 492000 Ext 3942 / 3941

Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Lincoln County Hospital

Lincoln LN2 5QY, United Kingdom

Hospital R&D contact (matched)

Ms Hannah Finch

hannah.finch9@nhs.net01522 573941 ext 582059-

Liverpool Heart & Chest Hospital

Liverpool L14 3PE, United Kingdom

Barts Heart Centre

London EC1A 7BE, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

St Bartholomew's Hospital - Barts Heart Centre

London EC1A 7BE, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

King's College Hospital - Cardiology

London SE5 9RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Kings College Hospital

London SE5 9RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

The James Cook University Hospital - Cardiology

Middlesbrough TS4 3BW, United Kingdom

Freeman Hospital, Newcastle

Newcastle upon Tyne NE7 7DN, United Kingdom

Derriford Hospital - Plymouth

Plymouth PL6 5FP, United Kingdom

Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

Queen Alexandra Hospital - Cardiology

Portsmouth PO6 3LY, United Kingdom

Queen Alexandra Hospital

Portsmouth PO6 3LY, United Kingdom

Hospital R&D contact (matched)

Joe Shoebridge

research.office@porthosp.nhs.uk023 9228 6236

Northern General Hospital

Sheffield S5 7AU, United Kingdom

Hospital R&D contact (matched)

Rachel Pollard (Governance Manager)

r.pollard@nhs.net03033 306366

Lister Hospital

Stevenage SG1 4AB, United Kingdom

Hospital R&D contact (matched)

Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)

mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069

Morriston Hospital

Swansea SA6 6NL, United Kingdom

Musgrove Park Hospital

Taunton TA1 5DA, United Kingdom

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065
Data sourced from ClinicalTrials.gov · Last verified: 2026-09