Vai al contenuto principale
xMedica

NCT07181109ClinicalTrials.gov

Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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…

Fase 311.000 partecipanti ricercati1153 centri35 paesi

Categorie

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Present: Registered before enrolment beganFirst posted 2025-09-18; recorded start 2025-09-22
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Present: Participants are randomly assignedAllocation is recorded as randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Present: Uses blinding (masking)A masking level is recorded in the record
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 50 other studies in this databaseCounted from the lead sponsor named in the record (Alnylam Pharmaceuticals)
  • Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 995 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 11,000 participants (target), run at 1,153 sites, across 35 countries.

How this score is built
  • Enrolment38/40

    11,000 participants (target)

  • Site count25/25

    995 sites

  • Country count15/15

    34 countries

  • Planned duration10/10

    Planned over about 61 months

  • Sponsor scale6/10

    Alnylam Pharmaceuticals has led 53 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

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.

Patologie

  • High Risk Cardiovascular Disease
  • Hypertension
  • High Cardiovascular Risk

Idoneità

Idoneità
SessoTutti
Età18 YearsNessun massimo
Volontari saniNo

Idoneità come riportata nel registro

Inclusion Criteria: * 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 Criteria: * Has known history of secondary hypertension * Has symptomatic orthostatic hypotension * 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento11.000 partecipanti ricercati

Sponsor e collaboratori

  • Alnylam Pharmaceuticals Sponsor
  • Hoffmann-La Roche Collaboratori

Bracci e interventi

  • Zilebesiran 300 mgEXPERIMENTAL

    Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.

  • PlaceboPLACEBO_COMPARATOR

    Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.

Interventi

  • Farmaco Placebo

    Placebo will be administered SC

  • Farmaco Zilebesiran

    Zilebesiran will be administered SC

Esiti misurati

  1. Esito primario

    Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)

    Orizzonte temporale Up to approximately 5 years

  2. Esito secondario

    Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6

    Orizzonte temporale Baseline and Month 6

  3. Esito secondario

    Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke

    Orizzonte temporale Up to approximately 5 years

  4. Esito secondario

    Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)

    Orizzonte temporale Up to approximately 5 years

  5. Esito secondario

    Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization

    Orizzonte temporale Up to approximately 5 years

  6. Esito secondario

    Time to All-cause Death

    Orizzonte temporale Up to approximately 5 years

Date

Date
Data di inizio22 settembre 2025 (effettiva)
Conclusione primaria23 settembre 2030 (stimata)
Conclusione23 settembre 2030 (stimata)
Prima pubblicazione18 settembre 2025 (effettiva)
Ultimo aggiornamento18 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

922 centri stanno reclutando

Argentina

Argentina
StrutturaCittàStato o regioneStato
Clinical Trial SiteBahía BlancaIn reclutamento
Clinical Trial SiteBahía BlancaIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresNon ancora in reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteBuenos AiresIn reclutamento
Clinical Trial SiteCiudadelaIn reclutamento
Clinical Trial SiteCoronel SuárezIn reclutamento
Clinical Trial SiteCorrientesIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteCórdobaIn reclutamento
Clinical Trial SiteEsperanzaIn reclutamento
Clinical Trial SiteFormosaIn reclutamento
Clinical Trial SiteGeneral San MartínIn reclutamento
Clinical Trial SiteGranadero BaigorriaIn reclutamento
Clinical Trial SiteLanús EsteIn reclutamento
Clinical Trial SiteMar del PlataIn reclutamento
Clinical Trial SiteMar del PlataIn reclutamento
Clinical Trial SiteMorónIn reclutamento
Clinical Trial SiteQuilmesNon ancora in reclutamento
Clinical Trial SiteRamos MejíaIn reclutamento
Clinical Trial SiteRosarioNon ancora in reclutamento
Clinical Trial SiteRosarioIn reclutamento
Clinical Trial SiteRosarioIn reclutamento
Clinical Trial SiteRosarioIn reclutamento
Clinical Trial SiteRosarioIn reclutamento
Clinical Trial SiteRosarioIn reclutamento
Clinical Trial SiteRosarioIn reclutamento
Clinical Trial SiteRío CuartoIn reclutamento

Nella scheda del registro sono indicati altri 1103 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 18 settembre 2026

    Data di conclusione anticipata

    Primary completion advanced 7 days

    2030-09-302030-09-23

  2. 18 settembre 2026

    Centro aggiunto

    48 sites added (1153 total)

    11051153

  3. 19 agosto 2026

    Centro aggiunto

    110 sites added (1105 total)

    9951105