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Zilebesiran for High Blood Pressure and Cardiovascular Risk

This study is testing a medication called zilebesiran in people with high blood pressure (hypertension) that isn't well-controlled, and who also have existing heart disease or a high risk for it. The goal is to see if zilebesiran, given as an injection under the skin, can lower the chance of serious heart-related problems like heart attack, stroke, heart failure, or death from heart disease. You could be eligible if you are 18 or older with established heart disease, or 55 or older with a high risk for heart disease, and are already taking at least two blood pressure medications. The study will continue until a certain number of these heart-related events have occurred, which could be up to approximately 5 years.

Study design
This is an interventional study comparing zilebesiran to a placebo (an inactive substance) in approximately 11,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 5 years to track cardiovascular events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07181109

Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

Recruiting
PHASE3Ages 18+InterventionalTreatment
Alnylam Pharmaceuticals
~11,000 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:ZilebesiranPlacebo

At a glance

Recruiting sites
753 of 1105 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Up to approximately 5 years

Conditions

High Risk Cardiovascular Disease
Hypertension
High Cardiovascular Risk

Explore related trials

Cardiovascular DisorderHypertension

Where it's being run

1105 sites across 70 states
Poland66
Argentina61
United Kingdom50
Texas48
Spain48
Bulgaria47
Germany46
China43

Study leadership

  • Medical Director · STUDY_DIRECTOR · Alnylam Pharmaceuticals

Who to contact

Clinical Trial Information Line
[email protected]
1-877-ALNYLAM
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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)Up to approximately 5 years