NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hypertension not adequately controlled and with either established CVD or high risk for CVD
Date of first enrollment	31/10/2025
Target sample size	450
Countries of recruitment	Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Italy,Japan,South Korea,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Serbia,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan
Study type	Interventional
Intervention(s)	Participants will be administered 300 mg zilebesiran or placebo subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.

Outcome(s)

Primary Outcome	To evaluate whether zilebesiran versus placebo reduces the risk of CV death, nonfatal MI, nonfatal stroke, or HF events
Secondary Outcome	To evaluate whether zilebesiran versus placebo reduces mean seated office SBP To evaluate whether zilebesiran versus placebo reduces the risk of nonfatal CV events and CV mortality To evaluate whether zilebesiran versus placebo reduces the risk of all-cause mortality

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1.Is 18 years or older for patients with established cardiovascular disease (CVD) 2.Is 55 years or older for patients with high risk for CVD 3.Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD 4.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
Exclude criteria	1.Has known history of secondary hypertension 2.Has symptomatic orthostatic hypotension 3.Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) 4.Has total serum bilirubin > 1.5 x ULN 5.Has international normalized ratio (INR) > 1.5 6.Has serum potassium > 4.8 mEq/L 7.Has estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2