Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established C… (NCT07181109) | Clinical Trial Compass
RecruitingPhase 3
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
United States, Argentina, Australia11,000 participantsStarted 2025-09-22
Plain-language summary
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is 18 years or older for patients with established cardiovascular disease (CVD)
* Is 55 years or older for patients with high risk for CVD
* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
Exclusion Criteria:
* Has known history of secondary hypertension
* Has symptomatic orthostatic hypotension
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN)
* Has total serum bilirubin \>1.5×ULN
* Has international normalized ratio (INR) \>1.5
* Has serum potassium \>4.8 mEq/L
* Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring something called a 'composite endpoint' that includes heart attack, stroke, heart failure events, and cardiovascular death — can you help me understand which of those outcomes are most relevant to my specific situation, and what my current risk level looks like?
2Zilebesiran appears to be a newer type of blood pressure treatment, and this is a Phase 3 trial, meaning it's being tested in a large group of people but hasn't yet completed the full approval process — given that, how does what's currently known about its safety compare to the blood pressure medications I'm already taking or could take?
3Since the trial is specifically for people whose hypertension isn't adequately controlled and who already have established cardiovascular disease or high cardiovascular risk, do you think my blood pressure and risk profile actually fit that description, and would it be worth exploring before trying other standard options?
4Participating in a long-term outcomes trial like this — where they're tracking serious events like heart attacks and strokes — could involve a significant time commitment with many visits and follow-ups; what would that schedule realistically look like for someone in my situation, and is that manageable given my other health needs?
5Are there existing approved medications or treatment combinations that could better control my blood pressure right now, and how would you weigh those against enrolling in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)