Zilebesiran for uncontrolled high blood pressure in people with or at high risk for cardiovascular disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized, placebo-controlled, event-driven trial compares zilebesiran with placebo in adults with treated but inadequately controlled hypertension who either have established cardiovascular disease or are at high cardiovascular risk. Participants must be on stable therapy with at least two standard antihypertensive medications, including a thiazide/thiazide-like or loop diuretic. The primary outcome is a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events, and the study will continue until a prespecified number of adjudicated events have occurred. Dosing and follow-up are managed at participating clinical sites with blinded outcome adjudication.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Trial Site
  Birmingham, Alabama, United States Recruiting
• Clinical Trial Site
  Birmingham, Alabama, United States Recruiting
• Clinical Trial Site
  Fairhope, Alabama, United States Recruiting
• Clinical Trial Site
  Foley, Alabama, United States Recruiting
• Clinical Trial Site
  Huntsville, Alabama, United States Recruiting
• Clinical Trial Site
  Huntsville, Alabama, United States Recruiting

+1140 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trial Information Line
• Email: clinicaltrials@alnylam.com
• Phone: 1-877-ALNYLAM

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.