ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
The ZEUS clinical trial is testing a new medicine called ziltivekimab for adults who have both heart disease and chronic kidney disease, alongside high levels of inflammation in the body. Inflammation is the body's natural response to illness, but long-term inflammation can damage blood vessels and kidneys. Researchers want to find out if reducing this inflammation with monthly injections of ziltivekimab can help prevent serious problems like heart attacks, strokes, and kidney failure. Participants will be placed by chance into one of two groups. One group receives ziltivekimab, and the other receives a dummy treatment called a placebo. Neither the patient nor their doctor will choose which group they are in. Everyone taking part will continue to receive their standard medical care and will have regular check-ups with the study team to monitor their health throughout the trial.
At a glance
What is this study about?
Many people living with long-term kidney disease also develop problems with their heart and blood vessels. When blood vessels become clogged or stiff, it increases the risk of heart attacks and strokes. Doctors have found that long-term swelling inside the body, known as systemic inflammation, plays a major role in making both heart and kidney conditions worse over time.
Ziltivekimab is an experimental medicine designed to calm this inflammation. It works by blocking a specific signal in the immune system that causes blood vessels to stay irritated. The ZEUS trial is a large international Phase III study designed to confirm whether lowering this inflammation truly protects patients from life-threatening cardiovascular problems.
During the trial, researchers will carefully track whether participants experience fewer heart attacks, strokes, emergency hospital visits, or declines in kidney function compared to those not taking the drug. The results could provide a new way to help people who remain at high risk of heart and kidney problems despite taking standard treatments.
Key takeaways
- The ZEUS trial tests if a medicine called ziltivekimab protects the heart and kidneys by lowering inflammation.
- It is aimed at adults who have both chronic kidney disease and established heart or blood vessel disease.
- Participants receive either the study drug or a dummy placebo injection once a month alongside their normal care.
- Regular health checks and blood tests are carried out to monitor your safety throughout the study.
- Joining is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have established cardiovascular disease (such as a past heart attack, stroke, or narrowed blood vessels) alongside chronic kidney disease. Doctors will also test blood samples to confirm that a person has ongoing inflammation in their body.
Because safety is the top priority, people with certain other severe medical conditions might not be able to take part. For instance, individuals with active, serious infections, severe liver problems, or very advanced kidney failure already requiring dialysis may not be eligible, as calming the immune system could carry higher risks for them.
A doctor or research nurse at a participating NHS hospital will review your complete medical history, medications, and blood results to confirm whether this study is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You have been diagnosed with chronic kidney disease.
- You have a history of heart disease, stroke, or poor blood circulation.
- A blood test shows ongoing inflammation in your body.
- You are willing to attend regular hospital check-ups and receive monthly injections.
What does participation involve?
Taking part in the ZEUS trial involves regular contact with a specialist research team over several years. Participants receive their assigned study treatment as an injection just under the skin, usually once a month. Half of the participants will receive ziltivekimab, while the other half will receive an inactive dummy injection (placebo) so scientists can make a fair comparison.
You will attend clinic visits for routine health checks, including blood pressure measurements, heart traces (ECGs), and blood and urine tests to monitor your kidneys and immune system. Between visits, the team may contact you by telephone to check how you are feeling. You will continue to take all your standard prescribed medicines, and your trial doctor will keep your GP informed throughout your time in the study.
Potential risks and benefits
Locations (18)
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- —UnverifiedLithuania
- —UnverifiedNetherlands
- —UnverifiedHungary
- —UnverifiedPoland
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- —UnverifiedGermany
- —UnverifiedCroatia
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedRomania
- —UnverifiedItaly
Common questions
What is the ZEUS study testing?
It is testing whether an anti-inflammatory medicine called ziltivekimab can lower the risk of heart attacks, strokes, and kidney damage in high-risk patients.
Will I definitely receive the active medicine?
No. You will be placed into a group by chance. You have an equal chance of receiving ziltivekimab or an inactive dummy injection known as a placebo.
Can I keep taking my regular prescriptions?
Yes. This trial adds the study medicine on top of your usual standard care. You should not stop any prescribed medicines without speaking to your doctor.
How is the study medicine given?
It is given as a small injection under the skin, typically into the tummy or thigh, once every month.
What happens if I change my mind about taking part?
You can leave the study at any point without giving a reason. Your standard NHS medical care and relationship with your doctors will stay exactly the same.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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