ZEUS A research study to look at how ziltivekimab works compared to placebo in people with cardiovascular disease chronic kidney disease and inflammation

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Atherosclerotic Cv Disease
  • Age: Between 18 years - 99 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Provide written informed consent
    2. Evidence of atherosclerotic cardiovascular disease (ASCVD) by one or more of the following:
      • Coronary heart disease
      • Cerebrovascular disease
      • Symptomatic peripheral artery disease (PAD)
    3. Estimated glomerular filtration rate (eGFR) = 15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
    4. Serum hs-CRP = 2 mg/L at screening

You may not be eligible for this study if the following are true:

    1. Known or suspected hypersensitivity to study intervention (s) or related products
    2. Previous participation in this study
    3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method
    4. Participation (i.e., signed informed consent) in any interventional clinical study of an approved or non-approved investigational medicinal product within 30 days prior to screening
    5. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
    6. Inadequate standard of care treatment which in the investigator's opinion makes the participant's participation in the study inappropriate
    7. Diagnosis of human immunodeficiency virus (HIV) and not receiving a stable antiretroviral regimen
    8. Active hepatitis C (positive anti-HCV and detectable HCV RNA) or hepatitis B (positive HBsAg)
    9. Current (or within 90 days of visit 1) chronic or intermittent hemodialysis or peritoneal dialysis
    10. Clinical evidence of, or suspicion of, active infection at the discretion of the investigator
    11. History of recurrent serious infections (infections leading to hospitalization or use of i.v. antibiotics) in the 12 months prior to randomization, at the discretion of the investigator
    12. History or evidence of untreated latent tuberculosis (TB)
    13. History of gastrointestinal perforation.
    14. History of active diverticulitis in the 5 years prior to randomization
    15. History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization
    16. Myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 60 days prior to randomisation
    17. Uncontrolled hypertension
    18. Planned coronary, carotid or peripheral artery revascularization
    19. Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomization (visit 2) or any major surgical procedure planned at the time of randomization (visit 2)
    20. Chronic heart failure
    21. History of bone marrow or solid organ transplant or anticipated to receive an organ transplant during the study
    22. Received a live or attenuated-live vaccine product within 4 weeks of study intervention
    23. Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals at screening
    24. Use of systemic immunosuppressive drugs
    25. Use of anti-IL-6 products at screening (visit 1) or anticipated use of such drugs any time during the study

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.