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
- A Coruña, Alcalá de Henares, Alicante, Antequera, Badajoz, Barcelona, Burjassot, Cadiz, Centelles, Córdoba, El Palmar, Figueres, Girona, Huelva, Jaén, L'Hospitalet de Llobregat, Lugo, Madrid, Málaga, Marbella, Palma de Mallorca, Pamplona, Peralada, Pozuelo de Alarcón, Salamanca, San Sebastián de los Reyes, Santiago de Compostela, Segovia, Seville, Tarragona, Torrejón de Ardoz, Valencia, Valladolid, and Vigo, SpainSee the 34 sites
- Phase
- Phase 3
Where in Spain
- A CoruñaA Coruña, SpainTaking people
- Alcalá de HenaresAlcalá de Henares, SpainTaking people
- AlicanteAlicante, SpainTaking people
- AntequeraAntequera, SpainTaking people
- BadajozBadajoz, SpainTaking people
- BarcelonaBarcelona, SpainTaking people
- BurjassotBurjassot, SpainTaking people
- CadizCadiz, SpainTaking people
- CentellesCentelles, SpainTaking people
- CórdobaCórdoba, SpainTaking people
- El PalmarEl Palmar, SpainTaking people
- FigueresFigueres, SpainTaking people
- GironaGirona, SpainTaking people
- HuelvaHuelva, SpainTaking people
- JaénJaén, SpainTaking people
- L'Hospitalet de LlobregatL'Hospitalet de Llobregat, SpainTaking people
- LugoLugo, SpainTaking people
- MadridMadrid, SpainTaking people
- MálagaMálaga, SpainTaking people
- MarbellaMarbella, SpainTaking people
- Palma de MallorcaPalma de Mallorca, SpainTaking people
- PamplonaPamplona, SpainTaking people
- PeraladaPeralada, SpainTaking people
- Pozuelo de AlarcónPozuelo de Alarcón, SpainTaking people
- SalamancaSalamanca, SpainTaking people
- San Sebastián de los ReyesSan Sebastián de los Reyes, SpainTaking people
- Santiago de CompostelaSantiago de Compostela, SpainTaking people
- SegoviaSegovia, SpainTaking people
- SevilleSeville, SpainTaking people
- TarragonaTarragona, SpainTaking people
- Torrejón de ArdozTorrejón de Ardoz, SpainTaking people
- ValenciaValencia, SpainTaking people
- ValladolidValladolid, SpainTaking people
- VigoVigo, SpainTaking 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.