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Taking people in BrazilPhase 3

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

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 Brazil

  • AracajuHospital not named in the registryTaking people
  • Belo Horizonte, Minas GeraisHospital not named in the registryTaking people
  • BlumenauHospital not named in the registryTaking people
  • BotucatuHospital not named in the registryTaking people
  • Bragança PaulistaHospital not named in the registryTaking people
  • Brasília, Federal DistrictHospital not named in the registryTaking people
  • Campina Grande do SulHospital not named in the registryTaking people
  • CampinasHospital not named in the registryTaking people
  • ColatinaHospital not named in the registryTaking people
  • Curitiba, ParanáHospital not named in the registryTaking people
  • Fortaleza, ParanáHospital not named in the registryTaking people
  • JoinvilleHospital not named in the registryTaking people
  • MaceióHospital not named in the registryTaking people
  • NatalHospital not named in the registryTaking people
  • Porto Alegre, Rio Grande do SulHospital not named in the registryTaking people
  • Rio de JaneiroHospital not named in the registryTaking people
  • Salvador, Estado de BahiaHospital not named in the registryTaking people
  • Santo AndréHospital not named in the registryTaking people
  • São Bernardo do CampoHospital not named in the registryTaking people
  • São JoséHospital not named in the registryTaking people
  • São José do Rio PretoHospital not named in the registryTaking people
  • São José dos CamposHospital not named in the registryTaking people
  • São Paulo, Estado de BahiaHospital not named in the registryTaking people
  • Sorocaba, São PauloHospital not named in the registryTaking people
  • TatuíHospital not named in the registryTaking people
  • VitóriaHospital not named in the registryNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT07181109 · EU CTIS 2025-522960-34-00