Recruiting
Phase 3

Ziltivekimab

Sponsor:

Novo Nordisk A/S

Code:

NCT06118281

Conditions

Cardiovascular Risk

Acute Myocardial Infarction (AMI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ziltivekimab

Placebo

Study Details

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.

Conditions

Cardiovascular Risk

Acute Myocardial Infarction (AMI)

Study ID

NCT06118281

Start date

Jun 25, 2024

Status verified date

Apr, 2026

Completion date

Dec 14, 2026

Anticipated

Primary completion date

Dec 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

10000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: Placebo ziltivekimab

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.

Interventions

Ziltivekimab

Ziltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly.

Placebo

Placebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.

Primary outcome measure

  • 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 [ Time Frame: From randomisation (month 0) to end-of-study (up to 25 months) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Winter Haven Hospital

Recruiting

Winter Haven, Florida, United States, 33881

Cardiolg Assoc Rsch LLC_Tupelo

Recruiting

Tupelo, Mississippi, United States, 38801

Jacobi Medical Center

Recruiting

The Bronx, New York, United States, 10461

Trinity Medical Group

Recruiting

Minot, North Dakota, United States, 58701

Chambersburg Hospital

Recruiting

Chambersburg, Pennsylvania, United States, 17201

Methodist Healthcare System of San Antonio

Recruiting

San Antonio, Texas, United States, 78229

New Brunswick Heart Centre

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

QE II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

William Osler Hel Bra Civic Hs

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Southlake Regional Hlth Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2R2

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-04-14.