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
- Aracaju, Belo Horizonte, Blumenau, Botucatu, Bragança Paulista, Brasília, Campina Grande do Sul, Campinas, Colatina, Curitiba, Fortaleza, Joinville, Maceió, Natal, Porto Alegre, Rio de Janeiro, Salvador, Santo André, São Bernardo do Campo, São José, São José do Rio Preto, São José dos Campos, São Paulo, Sorocaba, Tatuí, and Vitória, BrazilSee the 26 sites
- Phase
- Phase 3
Where in Brazil
- AracajuAracaju, BrazilTaking people
- Belo HorizonteBelo Horizonte, BrazilTaking people
- BlumenauBlumenau, BrazilTaking people
- BotucatuBotucatu, BrazilTaking people
- Bragança PaulistaBragança Paulista, BrazilTaking people
- BrasíliaBrasília, BrazilTaking people
- Campina Grande do SulCampina Grande do Sul, BrazilTaking people
- CampinasCampinas, BrazilTaking people
- ColatinaColatina, BrazilTaking people
- CuritibaCuritiba, BrazilTaking people
- FortalezaFortaleza, BrazilTaking people
- JoinvilleJoinville, BrazilTaking people
- MaceióMaceió, BrazilTaking people
- NatalNatal, BrazilTaking people
- Porto AlegrePorto Alegre, BrazilTaking people
- Rio de JaneiroRio de Janeiro, BrazilTaking people
- SalvadorSalvador, BrazilTaking people
- Santo AndréSanto André, BrazilTaking people
- São Bernardo do CampoSão Bernardo do Campo, BrazilTaking people
- São JoséSão José, BrazilTaking people
- São José do Rio PretoSão José do Rio Preto, BrazilTaking people
- São José dos CamposSão José dos Campos, BrazilTaking people
- São PauloSão Paulo, BrazilTaking people
- SorocabaSorocaba, BrazilTaking people
- TatuíTatuí, BrazilTaking people
- VitóriaVitória, BrazilNot yet recruiting
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.