ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
Summary
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 get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Timeline
- Start
- 2021-08-30
- Primary completion
- 2026-06-09
- Completion
- 2026-06-09
Publications
- Byambaa E, Roshanravan B, Berglund L. Lipoprotein(a) and CKD: Insights into New Therapeutic Opportunities. Clin J Am Soc Nephrol. 2025 Dec 2. doi: 10.2215/CJN.0000000968. Online ahead of print.
- Mohammadnia N, van Broekhoven A, Bax WA, Eikelboom JW, Mosterd A, Fiolet ATL, Tijssen JGP, Thompson PL, de Kleijn DPV, Tsimikas S, Cornel JH, Yeang C, El Messaoudi S. Interleukin-6 modifies Lipoprotein(a) and oxidized phospholipids associated cardiovascular disease risk in a secondary prevention cohort. Atherosclerosis. 2025 Jun;405:119211. doi: 10.1016/j.atherosclerosis.2025.119211. Epub 2025 Apr 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ziltivekimab B | Unknown | — | Subcutaneous |
| Subject | Ziltivekimab C | Unknown | — | Subcutaneous |