ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation (ZEUS)

STUDY OVERVIEW

This study by NovoNordisk A/S aims to assess whether ziltivekimab reduces the risk of cardiovascular events in individuals with cardiovascular disease, chronic kidney disease, and inflammation. Participants will receive either ziltivekimab or a placebo, determined by chance, administered monthly via pre-filled syringe injections into a skinfold. The study, spanning up to 4 years with approximately 20 clinic visits, involves blood and urine sample collections, as well as heart examinations using echocardiography and electrocardiogram. Pregnant, breastfeeding, or planning to become pregnant women are ineligible to participate.

STUDY GOALS

The goal of this study is to investigate the efficacy and safety of ziltivekimab in reducing the risk of cardiovascular events in individuals with chronic kidney disease and inflammation, alongside evidence of atherosclerotic cardiovascular disease, while also evaluating its impact on serum high-sensitivity C-reactive protein levels.

LOCATION

El Paso, Texas: Texas Academy of Diabetes, Thyroid and Endocrine

INCLUSION CRITERIA

  • Chronic kidney disease defined as:

    • Estimated glomerular filtration rate (eGFR) ≥ 15 and < 60 mL/min/1.73 m² (using CKD-EPI creatinine equation).

    • Urinary albumin-to-creatinine ratio (UACR) ≥ 200 mg/g and eGFR ≥ 60 mL/min/1.73 m² (using CKD-EPI creatinine equation).

  • Serum high-sensitivity C-reactive protein (hs-CRP) ≥ 2 mg/L.

  • Atherosclerotic cardiovascular disease (ASCVD) evidenced by:

    • Coronary heart disease: history of MI, prior coronary revascularization, or ≥ 50% stenosis in major coronary artery.

    • Cerebrovascular disease: history of stroke, carotid artery revascularization, or ≥ 50% stenosis in carotid artery.

    • Symptomatic peripheral artery disease (PAD): intermittent claudication with ABI ≤ 0.90, ≥ 50% stenosis in peripheral artery, prior peripheral artery revascularization, or lower extremity amputation due to atherosclerotic disease.

exclusion criteria

  • Clinical evidence or suspicion of active infection.

  • Myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 60 days prior to randomization.

  • Planned coronary, carotid, or peripheral artery revascularization known on the day of randomization.

  • Major cardiac, non-cardiac, or endoscopic surgery within 60 days prior to randomization, or planned major surgical procedure at randomization.

For more information, visit ClinicalTrials.gov.