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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack

Effects of Ziltivekimab Versus Placebo on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-infrared Spectroscopy and Optical Coherence Tomography Imaging Study

A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack (NCT07301034) is a Phase 3 interventional studying Myocardial Infarction, sponsored by Novo Nordisk A/S. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The study is testing the effect of ziltivekimab on reducing plaque in the blood vessels of the heart, specifically aiming to manage or reduce atherosclerotic plaque. The purpose of the study is to determine whether ziltivekimab can effectively reduce this plaque. Participants will either receive ziltivekimab (the active medicine) or a placebo (a dummy medicine with no effect on the body), with the treatment assignment decided by chance. It is important to note that ziltivekimab is not yet approved in any country or region worldwide; therefore, it is a new medicine that doctors cannot prescribe. The study will last for about 15 months.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Myocardial Infarction, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 332 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - willing to sign a consent form obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. - Age 18 years or above at the time of providing willing to sign a consent form. - Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with percutaneous coronary intervention (PCI): a. Acute ST-segment elevation myocardial infarction (STEMI) with all of the following: i. Onset of relevant pain suggestive of cardiac ischemia within less than or equal to (=\<) 24h of index angiography. ii. 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 to (\>=) 0.25 millivolts (mV) in men less than (\<) 40 years, \>=0.2 mV in men \>=40 years, or \>=0.15 mV in women in leads V2-V3; and/or \>=0.1 mV in all other leads. Non-ST segment elevation myocardial infarction (NSTEMI), with rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit. - At least two major native coronary arteries ‡ ("study vessels") each meeting the following criteria for intracoronary imaging immediately following the qualifying PCI procedure: 1. Angiographic evidence of a reduction in lumen diameter between \>20 and \<50 percent (%) by angiographic visual estimation. 2. Study vessel deemed to be accessible to imaging catheters and suitable for intracoronary imaging in the proximal (50 millimeter \[mm\]) segment ("study segment"). 3. Study vessel may not be a bypass (saphenous vein or arterial) graft or a bypassed native vessel. 4. Study vessel must not have undergone previous PCI within the study segment. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Age 18 years or above at the time of providing informed consent. * Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with percutaneous coronary intervention (PCI): a. Acute ST-segment elevation myocardial infarction (STEMI) with all of the following: i. Onset of relevant pain suggestive of cardiac ischemia within less than or equal to (=\<) 24h of index angiography. ii. 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 to (\>=) 0.25 millivolts (mV) in men less than (\<) 40 years, \>=0.2 mV in men \>=40 years, or \>=0.15 mV in women in leads V2-V3; and/or \>=0.1 mV in all other leads. Non-ST segment elevation myocardial infarction (NSTEMI), with rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit. * At least two major native coronary arteries ‡ ("study vessels") each meeting the following criteria for intracoronary imaging immediately following the qualifying PCI procedure: 1. Angiographic evidence of a reduction in lumen diameter between \>20 and \<50 percent (%) by angiographic visual estimation. 2. Study vessel deemed to be accessible to imaging catheters and suitable for intracoronary imaging in the proximal (50 millimeter \[mm\]) segment ("study segment"). 3. Study vessel may not be a bypass (saphenous vein or arterial) graft or a bypassed native vessel. 4. Study vessel must not have undergone previous PCI within the study segment. 5. A vessel which is candidate for intervention at the time of qualifying PCI or over the following 6 months in the judgment of the Investigator, cannot be a study vessel. 5\. Hemodynamic stability (as assessed by the treating physician) allowing the repetitive administration of nitroglycerine during the study specific imaging procedure. 6\. Ability to understand the requirements of the study and to provide informed consent 7. Willingness to undergo follow-up intracoronary imaging. 8. Possibility for randomisation and administration of the loading dose as early as possible after invasive procedure and latest within 48 hours after index PCI. Two study segments may be obtained in the same vessel (e.g. two study segments in the Right Coronary Artery \[RCA\] or Left Circumflex Artery \[LCX\]), at the investigators discretion, considering vessel anatomy (e.g. left or right dominance), and where suitable landmarks between segments are at least 40 mm apart and with vessel wall irregularities. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel. * Previous participation in this study. Participation is defined as randomisation. * Female of childbearing potential. * Participation in any other interventional or imaging clinical study within the past 30 days, or as parallel inclusion during the index hospitalization. * Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Left-main disease, defined as \>=50 percent (%) reduction in lumen diameter of the left main coronary artery by angiographic visual estimation * Three-vessel disease, defined as the presence of severe or significant coronary artery disease (CAD) on the basis of angiography, imaging, or physiology, in all three major epicardial territories (including major branches) that have an indication for revascularization or are too advanced to be treated. * History of coronary artery bypass surgery * Thrombolysis In Myocardial Infarction (TIMI) flow \<2 of the infarct-related artery after PCI * Unstable clinical status (hemodynamic or electrical instability. Hemodynamic instability defined as any of the following: Killip Class III or IV. Sustained and/or symptomatic hypotension (as assessed by the treating physician). * Significant coronary calcification or tortuosity deemed to preclude Intra-Vascular Ultrasound (IVUS), Near Infrared Spectroscopy (NIRS) and Optical Coherence Tomography (OCT) evaluation. * Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 months prior to screening. * Severe kidney impairment defined as any of the following: Previous or current estimated glomerular filtration rate \<30 milliliters per minute (ml/min) /1.73 square meter (m\^2) Chronic haemodialysis or peritoneal dialysis. \- Active liver disease or hepatic dysfunction defined as at least one of the following: Previously known or current hepatic encephalopathy (clinical evaluation) Previously known or current ascites (clinical evaluation) Jaundice (clinical evaluation) Previous oesophageal/gastric variceal bleeding Known hepatitis cirrhosis * Current use of anti-interleukin (IL)-6 products or anticipated use of such drugs any time during the study. * Use of systemic immunosuppressive drugs (both small molecules and biologics) or disease modifying anti-rheumatic drugs (DMARDs including both biologic DMARDs like anti- TNFalpha and conventional DMARDs like methotrexate) or anticipated chronic use of such drugs any time during the study. (Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary. Furthermore, temporary systemic immunosuppressive treatment of e.g., chronic obstructive pulmonary disease \[COPD\] exacerbations is allowed). * Known, or suspicion of, active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator. * History of recurrent serious infections (infections leading to hospitalization or use of intravenous (i.v.) antibiotics) within the past 12 months, at the discretion of the investigator. * Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals (Note: "Systemic" is defined as oral or i.v. drugs that are absorbed into the circulation. Antibiotics used to treat latent TB are exempted). * Absolute neutrophil count \<2x10 10\^9/L * Absolute platelet count \< 120 x10\^9/L * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>8 × upper limit of normal. Participants with increased levels of ALT or AST \<=8 x upper limit of normal (ULN) are eligible at the discretion of the investigator if the investigator considers the ALT or AST elevations to be caused by the current AMI. In case the elevation is considered related to other reasons than the current AMI, participants should be excluded when ALT or AST \>2.5 x(ULN). * Known (acute or chronic) hepatitis B or hepatitis C * Planned surgery within 12 months from the time of screening. * History of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, low risk prostate cancer, or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) at the discretion of the investigator. * Estimated life expectancy less than 2 years * Presence of risk factors for tuberculosis (TB) or history or evidence of latent TB such as (but not limited to): History or evidence of a positive TB test or chest X-ray compatible with latent TB and TB treatment initiated less than 28 days prior to randomisation. * Diagnosis of human immunodeficiency virus (HIV). * History of gastrointestinal perforation (Note: History of perforated appendicitis more than 5 years old is not exclusionary). * History of active diverticulitis within the past 5 years. * History of inflammatory bowel disease that has been clinically active within the past 12 months. * History of bone marrow or solid organ transplant or anticipated to receive an organ transplant during the study. * Received a live or attenuated-live vaccine product within 4 weeks of study intervention administration or expected to receive a live or attenuated-live vaccine product during the treatment period. * 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).

Treatments Being Tested

DRUG

Ziltivekimab

Participants will receive ziltivekimab subcutaneously.

DRUG

Ziltivekimab Placebo

Participants will receive placebo matched to ziltivekimab subcutaneously.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Medizinische Universität Wien
Vienna, Austria
Aalborg Universitetshospital Hjertemedicinsk Afdeling
Gistrup, Denmark
Rigshospitalet - Kardiologisk Forskningsenhed
København Ø, Denmark
Azienda Ospedaliera San Giovanni Addolorata
Rome, Lazio, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, Italy
DAI Scienze Mediche - UOC Endocrinologia
Messina, Sicily, Italy
Presidio Ospedaliero di Rivoli
Rivoli, To, Italy
Ospedale Policlinico San Martino
Genova, Italy
AOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia
Novara, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche
Orbassano, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Rome, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Radboudumc
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Universitäres Herzzentrum
Basel, Switzerland
Inselspital-Universitätsklinik für Kardiologie
Bern, Switzerland
HUG-Service de Cardiologie
Geneva, Switzerland
LUKS-Herzzentrum
Lucerne, Switzerland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07301034), the sponsor (Novo Nordisk A/S), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07301034 clinical trial studying?

The study is testing the effect of ziltivekimab on reducing plaque in the blood vessels of the heart, specifically aiming to manage or reduce atherosclerotic plaque. The purpose of the study is to determine whether ziltivekimab can effectively reduce this plaque. Participants will either receive ziltivekimab (the active medicine) or a placebo (a dummy medicine with no effect on the body), with the treatment assignment decided by chance. It is important to note that ziltivekimab is not yet approved in any country or region worldwide; therefore, it is a new medicine that doctors cannot prescribe… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07301034?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07301034?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07301034. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07301034. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.