NCT07301034

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Ziltivekimab	Participants will receive ziltivekimab subcutaneously.
DRUG	Ziltivekimab Placebo	Participants will receive placebo matched to ziltivekimab subcutaneously.

Timeline

• Start date: 2025-12-18
• Primary completion: 2028-11-14
• Completion: 2029-02-24
• First posted: 2025-12-24
• Last updated: 2026-03-11

Locations

20 sites across 6 countries: Austria, Denmark, Italy, Netherlands, Spain, Switzerland

Regulatory

• FDA-regulated drug study