Coming Soon
This study will begin recruiting soon.
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease (ZENITH)
About This Study
ZENITH is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of zilebesiran in reducing major adverse cardiovascular events. The study enrolls adults with hypertension not adequately controlled by standard of care who also have established cardiovascular disease or high cardiovascular risk. Investigators compare zilebesiran against placebo as an add-on therapy to determine its impact on a composite endpoint of cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure events. This event-driven trial continues until a predetermined number of adjudicated primary clinical outcome events occur.
Who Can Participate?
✓ 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