Cardiometabolic & kidneyRandomised controlled trial
Rationale, Design, and Baseline Clinical Characteristics of the Ziltivekimab Cardiovascular Outcomes Trial
- Rationale, design and baseline characteristics of the ZEUS randomised clinical trial
- multinational
- double-blind
- placebo-controlled
- event-driven
Authors' conclusion
The ZEUS randomized clinical trial will formally test the hypothesis that IL-6 inhibition with ziltivekimab will lower incident cardiovascular event rates and potentially slow kidney decline among participants with known ASCVD, CKD, and elevated hsCRP.
Study context
- Population
- Patients with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD) and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/Lrandomised 1:1
- Participants
- 6,376 patients
- Comparison
- Ziltivekimab vs placebo
- Primary endpoint
- 3-point MACE
Primary result
As reported in the abstract
Baseline characteristics · At randomization/baseline
- Mean age
- 69.5 years
- Female
- 27.5%
- Hypertension
- 92.0%
- Diabetes
- 65.7%
- HF
- 41.3%
- Mean estimated glomerular filtration rate (eGFR)
- 44.5 mL/min/1.73 m²
- Mean LDL-C
- 77.7 mg/dL
- Median hsCRP
- 4.5 mg/L
- Median IL-6
- 4.9 pg/mL
- SGLT2 inhibitor use at enrollment
- 36.8%
- GLP-1 receptor agonist use at enrollment
- 11.3%
Original publication
Rationale, Design, and Baseline Clinical Characteristics of the Ziltivekimab Cardiovascular Outcomes Trial. JAMA Cardiol. Published 1 January 2026. doi:10.1001/jamacardio.2025.4491
Summarised from the published abstract; every number is checked against it