Tests zilebesiran in adults with high-risk heart disease and high blood pressure
Tests zilebesiran against placebo in adults with uncontrolled high blood pressure and heart risk.
Plain-language title generated from the registry record
Registry title: Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Key facts
- Where
- Almada, Baixa Da Banheira, Carnaxide, Coimbra, Creixomil, Leiria, Lisbon, Loures, Ponte de Lima, Riachos, Santa Maria da Feira, Senhora da Hora, Setúbal, Touguinhó, Viana do Castelo, and Vila Nova de Gaia, PortugalSee the 16 sites
- Phase
- Phase 3
Where in Portugal
- AlmadaAlmada, PortugalTaking people
- Baixa Da BanheiraBaixa Da Banheira, PortugalTaking people
- CarnaxideCarnaxide, PortugalTaking people
- CoimbraCoimbra, PortugalTaking people
- CreixomilCreixomil, PortugalTaking people
- LeiriaLeiria, PortugalTaking people
- LisbonLisbon, PortugalTaking people
- LouresLoures, PortugalTaking people
- Ponte de LimaPonte de Lima, PortugalTaking people
- RiachosRiachos, PortugalTaking people
- Santa Maria da FeiraSanta Maria da Feira, PortugalTaking people
- Senhora da HoraSenhora da Hora, PortugalTaking people
- SetúbalSetúbal, PortugalTaking people
- TouguinhóTouguinhó, PortugalTaking people
- Viana do CasteloViana do Castelo, PortugalTaking people
- Vila Nova de GaiaVila Nova de Gaia, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alnylam Pharmaceuticals
- Trial code
- NCT07181109EU 2025-522960-34-00
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
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.
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 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; Has symptomatic orthostatic hypotension.