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
En bref
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…
Phase 311 000 participants recherchés1 153 sites35 pays
Catégories
Enregistré dans 1 registre
- ClinicalTrials.govNCT07181109Ouvrir cette fiche sur ClinicalTrials.govSynchronisé avant-hier
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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.
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
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
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.
Résumé
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.
Affections
- High Risk Cardiovascular Disease
- Hypertension
- High Cardiovascular Risk
Éligibilité
| Sexe | Tous |
|---|---|
| Âges | 18 Years – Aucun maximum |
| Volontaires sains | Non |
Éligibilité telle qu'elle figure dans le registre
Éligibilité en énoncés simples
Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.
Conception de l'étude
| Type d'étude | Interventionnelle |
|---|---|
| Phase | Phase 3 |
| Répartition | Randomisée |
| Modèle d'intervention | PARALLEL |
| Objectif principal | TREATMENT |
| Insu | QUADRUPLE (4) |
| Recrutement | 11 000 participants recherchés |
Promoteur et collaborateurs
- Alnylam Pharmaceuticals Promoteur
- Hoffmann-La Roche Collaborateurs
Groupes et interventions
- 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.
Interventions
- Médicament Placebo
Placebo will be administered SC
- Médicament Zilebesiran
Zilebesiran will be administered SC
Critères de jugement
Critère de jugement principal
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)
Délai Up to approximately 5 years
Critère de jugement secondaire
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
Délai Baseline and Month 6
Critère de jugement secondaire
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
Délai Up to approximately 5 years
Critère de jugement secondaire
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
Délai Up to approximately 5 years
Critère de jugement secondaire
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
Délai Up to approximately 5 years
Critère de jugement secondaire
Time to All-cause Death
Délai Up to approximately 5 years
Dates
| Date de début | 22 septembre 2025 (réelle) |
|---|---|
| Achèvement principal | 23 septembre 2030 (estimée) |
| Achèvement | 23 septembre 2030 (estimée) |
| Première publication | 18 septembre 2025 (réelle) |
| Dernière mise à jour | 18 septembre 2026 |
| Résultats publiés | Non précisé dans la fiche du registre |
| Statut vérifié pour la dernière fois | septembre 2026 |
Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.
Lieux
922 sites sont en recrutement
Argentina
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Clinical Trial Site | Bahía Blanca | En recrutement | |
| Clinical Trial Site | Bahía Blanca | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | Pas encore en recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Buenos Aires | En recrutement | |
| Clinical Trial Site | Ciudadela | En recrutement | |
| Clinical Trial Site | Coronel Suárez | En recrutement | |
| Clinical Trial Site | Corrientes | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Córdoba | En recrutement | |
| Clinical Trial Site | Esperanza | En recrutement | |
| Clinical Trial Site | Formosa | En recrutement | |
| Clinical Trial Site | General San Martín | En recrutement | |
| Clinical Trial Site | Granadero Baigorria | En recrutement | |
| Clinical Trial Site | Lanús Este | En recrutement | |
| Clinical Trial Site | Mar del Plata | En recrutement | |
| Clinical Trial Site | Mar del Plata | En recrutement | |
| Clinical Trial Site | Morón | En recrutement | |
| Clinical Trial Site | Quilmes | Pas encore en recrutement | |
| Clinical Trial Site | Ramos Mejía | En recrutement | |
| Clinical Trial Site | Rosario | Pas encore en recrutement | |
| Clinical Trial Site | Rosario | En recrutement | |
| Clinical Trial Site | Rosario | En recrutement | |
| Clinical Trial Site | Rosario | En recrutement | |
| Clinical Trial Site | Rosario | En recrutement | |
| Clinical Trial Site | Rosario | En recrutement | |
| Clinical Trial Site | Rosario | En recrutement | |
| Clinical Trial Site | Río Cuarto | En recrutement |
1 103 sites supplémentaires sont indiqués dans la fiche du registre.
Documents de l'étude
Aucun document n'est lié dans cette fiche du registre.
Évolution au fil du temps
- 18 septembre 2026
Date d'achèvement avancée
Primary completion advanced 7 days
2030-09-302030-09-23
- 18 septembre 2026
Site ajouté
48 sites added (1153 total)
11051153
- 19 août 2026
Site ajouté
110 sites added (1105 total)
9951105