Research Study: ZEUS
Condition:
cardiovascular risk, chronic kidney disease, inflammation
Study Sponsor: Novo Nordisk A/S
Study Investigator: Courtney Jordan Baechler, MD
Study Contact: Stephanie Ebnet
Stephanie.ebnet@allina.com
612-863-6286
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example, heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either receive ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment a participant receives is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same.
Eligibility Criteria:

Inclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
  • Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L at screening (visit 1)
  • Evidence of atherosclerotic cardiovascular disease (ASCVD) by one or more of the following within the last 5 years from screening:
    • Coronary heart disease defined as at least one of the following:
      • Documented history of MI
      • Prior coronary revascularisation procedure
      • Greater than or equal to 50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography
    • Cerebrovascular disease defined as at least one of the following:
      • Prior stroke of atherosclerotic origin
      • Prior carotid artery revascularisation procedure
      • Greater than or equal to 50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound.
    • Symptomatic peripheral artery disease (PAD) defined as at least one of the following:
      • Intermittent claudication with an ankle-brachial index (ABI) below or equal to 0.90 at rest
      • Intermittent claudication with a greater than or equal to 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound
      • Prior peripheral artery (excluding carotid) revascularisation procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!