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

Sponsor
Novo Nordisk A/S
Study ID
NCT07301034
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ziltivekimab — DRUG
    Participants will receive ziltivekimab subcutaneously.
  • Ziltivekimab Placebo — DRUG
    Participants will receive placebo matched to ziltivekimab subcutaneously.

Study Details

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.

Key Dates

Start date
Dec 18, 2025
Status verified
Mar 2026
Primary completion
Nov 14, 2028
Completion
Feb 24, 2029

Study Design

Enrollment
332 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ziltivekimab dose level 1 + standard of care (SOC)
    Participants receive dose level 1 of ziltivekimab along with standard of care (SOC) subcutaneously once monthly for 12 months.
  • Placebo Comparator: Placebo + SOC
    Participants receive a placebo along with standard of care (SOC) subcutaneously once monthly for 12 months.

Primary Outcome Measure

Change in percent atheroma volume (PAV) as determined by greyscale intravascular ultrasound (IVUS) in matched regions of interest [ Time Frame: From randomisation (week 0) to end-of-study (52-week) ]

Central Contacts

Related Studies