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Can a new drug cool down inflamed arteries and prevent heart attacks?

NCT ID NCT06263244

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether ziltivekimab, a drug that targets inflammation, can reduce swelling in the arteries of 40 people with coronary artery disease. Participants receive either the drug or a placebo, and researchers use advanced imaging and blood tests to measure changes. The goal is to see if this approach can lower inflammation, which is linked to heart attacks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ziltivekimab (a monoclonal antibody targeting IL-6)
What this could lead to
If it works, this could point toward a treatment that lowers inflammation in arteries, potentially reducing heart attack risk.
What could go wrong
This is a small, early-phase trial focused on imaging and lab markers, not clinical outcomes like heart attacks. The drug may not show clear benefits or could have side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 50 years and older. * Multi-vessel coronary artery disease (defined as CAD-RADS ≥2). * Serum hsCRP level ≥2 mg/L. Exclusion Criteria: * Coronary stents in situ. * Chronic or recent (\<1 month) (serious) infections and/or clinical signs of acute (serious) infection. * History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders. * Use of preventive systemic antibiotics (antibiotics used to treat latent tuberculosis are exempted). * Stable lipid lowering treatment for less than 4 weeks, including statins, ezetimibe and PCSK9 inhibition. * Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus (HIV) not on stable antiretroviral regimen * Uncontrolled diabetes (HbA1c \>90 mmol/mol). * Renal insufficiency, defined as eGFR \<45 ml/min/1.73 m2. * Platelet count \<120,000 and \>450,000 /mm3. * Elevated liver enzymes (\>3 ULN of liver transaminases), acute liver failure or known (severe) liver disease. * Premenopausal women not using birth-control. * History of gastrointestinal perforation, active diverticulitis (within 5 years) or active inflammatory bowel disease (within 12 months). * Uncontrolled hypertension (systolic \>180 mmHg; diastolic \>110 mmHg). * Diagnosis of (active) malignancy in last 5 years. * Standard contra-indications to 68Ga-DOTATATE PET, and CT based on physician's experience and current practices. * Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

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Conditions

The condition(s) this trial relates to.

atherosclerosis coronary artery disorder Inflammation inflammatory disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Inflammation

Contacts and locations

Locations

  • Amsterdam UMC, location AMC

    Amsterdam, 1105AZ, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.