Testing Zilebesiran against a placebo for high risk cardiovascular disease
Official title: 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
- Phase 3
- 2 groups
- Sites in Brampton, Burlington and 23 more cities
- Recruiting
Interventions
- Medication
Zilebesiran
Zilebesiran will be administered SC
- Medication
Placebo
Placebo will be administered SC
Canadian Sites (33)
19 of 33 recruiting
- Recruiting
Clinical Trial Site
Brampton
- Recruiting
Clinical Trial Site
Brampton
- Recruiting
Clinical Trial Site
Chicoutimi
- Recruiting
Clinical Trial Site
Etobicoke
- Recruiting
Clinical Trial Site
Etobicoke
- Recruiting
Clinical Trial Site
Greater Sudbury
- Recruiting
Clinical Trial Site
Laval
- Recruiting
Clinical Trial Site
Lévis
- Recruiting
Clinical Trial Site
Longueuil
- Recruiting
Clinical Trial Site
Mirabel
- Recruiting
Clinical Trial Site
Mississauga
- Recruiting
Clinical Trial Site
Moncton
- Recruiting
Clinical Trial Site
Montreal
- Recruiting
Clinical Trial Site
Québec
- Recruiting
Clinical Trial Site
Québec
- Recruiting
Clinical Trial Site
Richmond
- Recruiting
Clinical Trial Site
Scarborough
- Recruiting
Clinical Trial Site
Sherbrooke
- Recruiting
Clinical Trial Site
Sydney
- Not yet recruiting
Clinical Trial Site
Burlington
- Not yet recruiting
Clinical Trial Site
Cambridge
- Not yet recruiting
Clinical Trial Site
London
- Not yet recruiting
Clinical Trial Site
Moncton
- Not yet recruiting
Clinical Trial Site
Montreal
- Not yet recruiting
Clinical Trial Site
Peterborough
- Not yet recruiting
Clinical Trial Site
Québec
- Not yet recruiting
Clinical Trial Site
Rimouski
- Not yet recruiting
Clinical Trial Site
Saint-Jérôme
- Not yet recruiting
Clinical Trial Site
Sarnia
- Not yet recruiting
Clinical Trial Site
Scarborough
- Not yet recruiting
Clinical Trial Site
Sherbrooke
- Not yet recruiting
Clinical Trial Site
Trois-Rivières
- Not yet recruiting
Clinical Trial Site
Windsor
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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 careStandard of careThe treatment normally given for a condition outside a study.Read more → antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
Exclusion
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Zilebesiran.
Registry label: A: Zilebesiran 300 mg
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 11,000 people.
The study is currently expected to finish around September 2030.
The main measurement is taken over: Up to approximately 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to First Occurrence of a Composite EndpointEndpointThe specific thing a study measures to answer its question.Read more → of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit) — measured over Up to approximately 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07181109 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ZilebesiranDrug
Zilebesiran will be administered SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo will be administered SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 5 years.
The study as a whole is currently expected to finish around 2030-09-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 11,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 44 locations, including: Brampton, Canada; Burlington, Canada; Cambridge, Canada; Chicoutimi, Canada; Etobicoke, Canada; Greater Sudbury, Canada, and 38 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (20)
Clinical Trial Site
Flint, Michigan, United States
Clinical Trial Site
Lansing, Michigan, United States
Clinical Trial Site
Midland, Michigan, United States
Clinical Trial Site
Petoskey, Michigan, United States
Clinical Trial Site
Shelby, Michigan, United States
Clinical Trial Site
Southfield, Michigan, United States
Clinical Trial Site
Troy, Michigan, United States
Clinical Trial Site
Troy, Michigan, United States
Clinical Trial Site
Richfield, Minnesota, United States
Clinical Trial Site
Saint Cloud, Minnesota, United States
Clinical Trial Site
New Windsor, New York, United States
Clinical Trial Site
North Massapequa, New York, United States
Clinical Trial Site
Poughkeepsie, New York, United States
Clinical Trial Site
Riverhead, New York, United States
Clinical Trial Site
Rosedale, New York, United States
Clinical Trial Site
Saratoga Springs, New York, United States
Clinical Trial Site
The Bronx, New York, United States
Clinical Trial Site
West Seneca, New York, United States
Clinical Trial Site
Westfield, New York, United States
Clinical Trial Site
Bellevue, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.