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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose high blood pressure is not well controlled despite treatment, and who either have heart or blood vessel disease or are at high risk for it.
- Age
- 18 years or older if you already have cardiovascular disease; 55 years or older if you are at high risk for it.
- Sex
- All sexes can join.
- Disease stage
- Treated high blood pressure that is not adequately controlled, with established cardiovascular disease (coronary, cerebrovascular or peripheral artery disease) or a high risk for cardiovascular disease.
- Earlier treatment
- Must be on stable treatment with at least 2 standard blood pressure medicines, and one of them must be a thiazide, thiazide-like or loop diuretic.
Main reasons for not taking part
- Known history of secondary hypertension
- Symptomatic orthostatic hypotension
- Liver tests ALT or AST above 3 times the upper limit of normal
- Total serum bilirubin above 1.5 times the upper limit of normal
- Serum potassium above 4.8 mEq/L or eGFR below 30 mL/min/1.73m^2
Read by machine on 9 November 2026.
Where in Spain
- A CoruñaHospital not named in the registryTaking people
- Alcalá de HenaresHospital not named in the registryTaking people
- AlicanteHospital not named in the registryTaking people
- AntequeraHospital not named in the registryTaking people
- BadajozHospital not named in the registryTaking people
- BarcelonaHospital not named in the registryTaking people
- BurjassotHospital not named in the registryTaking people
- CadizHospital not named in the registryTaking people
- CentellesHospital not named in the registryTaking people
- CórdobaHospital not named in the registryTaking people
- El PalmarHospital not named in the registryTaking people
- FigueresHospital not named in the registryTaking people
- GironaHospital not named in the registryTaking people
- HuelvaHospital not named in the registryTaking people
- JaénHospital not named in the registryTaking people
- L'Hospitalet de Llobregat, BarcelonaHospital not named in the registryTaking people
- LugoHospital not named in the registryTaking people
- MadridHospital not named in the registryTaking people
- MálagaHospital not named in the registryTaking people
- MarbellaHospital not named in the registryTaking people
- Palma de MallorcaHospital not named in the registryTaking people
- PamplonaHospital not named in the registryTaking people
- PeraladaHospital not named in the registryTaking people
- Pozuelo de AlarcónHospital not named in the registryTaking people
- SalamancaHospital not named in the registryTaking people
- San Sebastián de los ReyesHospital not named in the registryTaking people
- Santiago de CompostelaHospital not named in the registryTaking people
- SegoviaHospital not named in the registryTaking people
- SevilleHospital not named in the registryTaking people
- TarragonaHospital not named in the registryTaking people
- Torrejón de ArdozHospital not named in the registryTaking people
- ValenciaHospital not named in the registryTaking people
- ValladolidHospital not named in the registryTaking people
- VigoHospital not named in the registryTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.