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ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
EU CTIS ID: 2023-506926-35-00
What this study is testing
To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Chronic kidney disease defined by one of the below: eGFR ≥15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation), OR UACR ≥200 mg/g and eGFR ≥60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation).
- Serum hs-CRP ≥2 mg/L
- Evidence of ASCVD by one or more of the following: Coronary heart disease defined as at least one of the following: Documented history of MI, prior coronary revascularisation procedure, or ≥50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography. Cerebrovascular disease defined as at least one of the following: Prior stroke of atherosclerotic origin, prior carotid artery revascularisation procedure, or ≥50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: Intermittent claudication with an ankle-brachial index (ABI) ≤ 0.90 at rest, intermittent claudication with a ≥50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound, prior peripheral artery (excluding carotid) revascularisation procedure, or lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis).
You likely can't join if
- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2).
- Planned coronary, carotid or peripheral artery revascularisation known on the day of randomisation (visit 2).
- Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Democratic People's Republic of
- Russian Federation
- Taiwan
- Brazil
- Ukraine
- United Kingdom
- China
- Serbia
- Thailand
- India
- Malaysia
- Japan
- South Africa
- Turkey
- Australia
- Argentina
- Canada
- Israel
- United States
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Democratic People's Republic of; Russian Federation; Taiwan; Brazil; Ukraine; United Kingdom and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.