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A study of ziltivekimab compared to placebo for reducing heart problems in patients who have had a heart attack

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at acute myocardial infarction, which is commonly known as a heart attack. There are two types of heart attack being studied: one called STEMI, which shows specific changes on a heart tracing, and another called NSTEMI, which may have different signs. The study will test a medication called ziltivekimab, which is given as an injection under the skin once a month. This medication works by blocking a substance in the body called interleukin-6 that is involved in inflammation. Some people in the study will receive ziltivekimab while others will receive placebo. All participants will continue to receive their standard care for heart attack treatment. The purpose of the study is to see if ziltivekimab can reduce the risk of major heart-related problems compared to placebo in people who have had a heart attack.

People who join this study will have recently been hospitalized for a heart attack and will have had a procedure to look at the blood vessels in their heart. They will also have at least one additional risk factor, such as a previous heart attack, diabetes requiring medication, reduced kidney function, previous stroke, disease in the neck or leg arteries, or blockages in multiple heart arteries. The study medication will be started as soon as possible after the heart procedure, within a specific time window depending on the type of heart attack. Treatment will continue for up to 22 months, with monthly injections given under the skin.

During the study, doctors will monitor participants for major heart-related events including death from heart problems, another heart attack, or stroke. The study will also look at other outcomes such as the need for procedures to open blocked heart arteries, hospitalizations for heart failure, which is when the heart cannot pump blood well enough, and overall survival. The goal is to determine whether ziltivekimab can help prevent these serious complications in people who have experienced a heart attack and are at higher risk for future heart problems.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and randomization

    After being hospitalized for a heart attack (also called acute myocardial infarction), an invasive procedure called angiography will be performed. This is a procedure that uses X-rays to view the blood vessels in the heart.

    If the heart attack is classified as STEMI (ST-elevation myocardial infarction), randomization and the first dose of study medication must be given as early as possible after the procedure, but no later than 36 hours after arriving at the hospital.

    If the heart attack is classified as NSTEMI (non-ST-elevation myocardial infarction), randomization and the first dose of study medication must be given as early as possible after the procedure, but no later than 72 hours after arriving at the hospital.

    Randomization means being assigned by chance to receive either ziltivekimab or placebo (an inactive substance that looks like the study medication but contains no active ingredient).

  2. Step 2

    First dose administration

    The first dose of study medication will be administered as an injection under the skin (subcutaneous injection).

    This dose will be given as early as possible after the heart procedure, following the time limits mentioned in the previous step.

    The study medication will be given in addition to standard care for heart attack.

  3. Step 3

    Monthly treatment phase

    After the first dose, the study medication (ziltivekimab or placebo) will be administered once monthly.

    Each dose will be given as an injection under the skin (subcutaneous injection).

    The study medication will continue to be given in addition to standard care for heart attack.

  4. Step 4

    Monitoring and follow-up visits

    Throughout the study, regular visits will be scheduled to monitor health status and check for any side effects.

    The study will monitor for major cardiovascular events, including cardiovascular death (death related to heart or blood vessel problems), heart attacks, and strokes.

    Additional monitoring will include checking for heart failure events, which may require hospitalization or urgent medical visits.

    The study will also track any procedures needed to restore blood flow to the heart arteries.

  5. Step 5

    Study completion

    The study is expected to continue until September 2026.

    The total duration of participation will depend on when enrollment occurs during the study period.

    Throughout the entire study period, both the study medication and standard care for heart attack will continue to be provided.

Who can join the trial?

8 criteria

  • You must be 18 years of age or older at the time of signing the informed consent form
  • You must be hospitalized for an acute heart attack, which is a sudden blockage of blood flow to the heart muscle, confirmed by a procedure called invasive angiography, which is a test using special x-rays to look at the blood vessels in your heart
  • Your heart attack must be type 1, meaning it was caused by a blockage in a heart artery rather than other causes like severe bleeding or infection
  • If you have a STEMI (a type of heart attack with specific changes on the heart tracing test called ECG), your symptoms must have started within 12 hours before arriving at the hospital, and your ECG must show specific elevation patterns in the heart tracing
  • If you have a NSTEMI (a type of heart attack without those specific ECG changes), your symptoms must have started or worsened within 24 hours before arriving at the hospital, and you must have elevated levels of cardiac troponin, which is a protein released when the heart muscle is damaged
  • You must be able to receive the first dose of the study medicine within 36 hours of hospital arrival for STEMI or within 72 hours for NSTEMI
  • You must have at least one of the following conditions based on your medical history: a previous heart attack, previous procedure to open blocked heart arteries, diabetes currently treated with medications to lower blood sugar, known chronic kidney disease with reduced kidney function, previous ischemic stroke which is a blockage of blood flow to the brain, known disease in the neck arteries or leg arteries with significant narrowing, or blockages in multiple heart arteries
  • If you had a recent heart attack within the past 30 days, your current heart attack must be in a different blood vessel than the previous one

Who cannot join the trial?

3 criteria

  • The source data does not contain specific exclusion criteria for this clinical trial
  • Exclusion criteria are the reasons why some patients cannot join a study, but this information was not provided in the available documents
  • Without the detailed exclusion criteria list, it is not possible to specify which patients would not be eligible to participate
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Investigated drugs

  • Ziltivekimab

    is an investigational medication being tested in this clinical trial. It is given as an injection under the skin (subcutaneously) once a month. This medication is being studied to see if it can help reduce the risk of major heart problems in people who have had a heart attack. In this trial, ziltivekimab will be added to the standard treatments that patients normally receive after a heart attack.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. It is used in clinical trials to compare against the actual medication being tested. Participants receiving the placebo will also receive standard care for their condition, just like those receiving ziltivekimab.

What is already known about the treatment

Ziltivekimab – Ziltivekimab is a human monoclonal antibody given as a subcutaneous injection (under the skin) once monthly, currently being studied in clinical trials for patients who have experienced a heart attack. This medication works by targeting and blocking interleukin-6, a protein in the body that causes inflammation, which helps reduce C-reactive protein levels, a marker of inflammation linked to heart disease risk. The drug is being investigated to determine if it can lower the chances of major heart-related problems when started shortly after a heart attack and added to standard treatment. At present, ziltivekimab is in the research phase and is not yet approved for routine medical use.

Investigated diseases

  • ST-Elevation Myocardial Infarction

    This is a severe type of heart attack that occurs when a coronary artery becomes completely blocked, preventing blood flow to a portion of the heart muscle. The blockage is usually caused by a blood clot that forms on a ruptured plaque in the artery wall. Without blood supply, the affected heart tissue begins to die within minutes to hours. This condition causes the ST segment on an electrocardiogram to become elevated, which is how doctors identify it. Patients typically experience severe chest pain, shortness of breath, sweating, and nausea. The damage to the heart muscle can affect the heart's ability to pump blood effectively.

  • Non-ST-Elevation Myocardial Infarction

    This is a type of heart attack where a coronary artery is partially blocked, reducing but not completely stopping blood flow to the heart muscle. The blockage is typically caused by a blood clot forming on an unstable plaque in the artery. Unlike ST-elevation myocardial infarction, this condition does not show ST segment elevation on an electrocardiogram, though other changes may be visible. The partial blockage still causes damage to heart tissue, but usually affects a smaller area than a complete blockage would. Symptoms include chest discomfort, shortness of breath, fatigue, and sometimes pain radiating to the arm, jaw, or back. The reduced blood flow can weaken the heart muscle and affect its pumping function.

  • Stroke

    This is a medical emergency that occurs when blood supply to part of the brain is interrupted or reduced, preventing brain tissue from receiving oxygen and nutrients. There are two main types: ischemic stroke caused by blocked blood vessels, and hemorrhagic stroke caused by bleeding in or around the brain. Brain cells begin to die within minutes of being deprived of blood supply. Common symptoms include sudden numbness or weakness of the face, arm, or leg, confusion, trouble speaking or understanding speech, vision problems, and difficulty walking. The effects depend on which part of the brain is affected and how much damage occurs. Stroke can result in temporary or permanent disabilities affecting movement, speech, memory, and other brain functions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506876-28-00Protocol codeEX6018-4979Estimated enrolment8 565 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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