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
- Bialystok, Bydgoszcz, Chojnice, Chorzów, Chrzanów, Częstochowa, Dębica, Gdansk, Gdynia, Giżycko, Grodzisk Mazowiecki, Jaksice, Katowice, Kędzierzyn-Koźle, Krakow, Lodz, Lublin, Malbork, Myszków, Olsztyn, Ostrowiec Świętokrzyski, Piotrkow Trybunalski, Poznan, Ruda Śląska, Rybnik, Rzeszów, Siedlce, Skierniewice, Sopot, Staszów, Świdnik, Tarnów, Torun, Ustroń, Warsaw, Wroclaw, and Zamość, PolandSee the 37 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 Poland
- BialystokBialystok, PolandTaking people
- BydgoszczBydgoszcz, PolandTaking people
- ChojniceChojnice, PolandTaking people
- ChorzówChorzów, PolandTaking people
- ChrzanówChrzanów, PolandTaking people
- CzęstochowaCzęstochowa, PolandTaking people
- DębicaDębica, PolandTaking people
- GdanskGdansk, PolandTaking people
- GdyniaGdynia, PolandTaking people
- GiżyckoGiżycko, PolandTaking people
- Grodzisk MazowieckiGrodzisk Mazowiecki, PolandTaking people
- JaksiceJaksice, PolandTaking people
- KatowiceKatowice, PolandTaking people
- Kędzierzyn-KoźleKędzierzyn-Koźle, PolandTaking people
- KrakowKrakow, PolandTaking people
- LodzLodz, PolandTaking people
- LublinLublin, PolandTaking people
- MalborkMalbork, PolandTaking people
- MyszkówMyszków, PolandTaking people
- OlsztynOlsztyn, PolandTaking people
- Ostrowiec ŚwiętokrzyskiOstrowiec Świętokrzyski, PolandTaking people
- Piotrkow TrybunalskiPiotrkow Trybunalski, PolandTaking people
- PoznanPoznan, PolandTaking people
- Ruda ŚląskaRuda Śląska, PolandTaking people
- RybnikRybnik, PolandTaking people
- RzeszówRzeszów, PolandTaking people
- SiedlceSiedlce, PolandTaking people
- SkierniewiceSkierniewice, PolandTaking people
- SopotSopot, PolandTaking people
- StaszówStaszów, PolandTaking people
- ŚwidnikŚwidnik, PolandTaking people
- TarnówTarnów, PolandTaking people
- TorunTorun, PolandTaking people
- UstrońUstroń, PolandTaking people
- WarsawWarsaw, PolandTaking people
- WroclawWroclaw, PolandTaking people
- ZamośćZamość, PolandTaking 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.