> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/zilebesiran-in-patients-with-hypertension-not-adequately-0286996e-b151-4f2a-b69a-0c70bff66021 > Record changed: 2026-10-13 # Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease NCT07181109 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) Participants 11,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) Lead sponsor Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) Start date 2025-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) Number of sites 1,105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Acronym** ZENITH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Short title** Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Dates **Completion date** 2030-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **First posted** 2025-09-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Primary completion date** 2030-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Start date** 2025-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Size and sites **Participants** 11,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Planned participants** 11,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Number of sites** 1,105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Lead sponsor** Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Identifiers **Registry ID** NCT07181109 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **ClinicalTrials.gov ID** NCT07181109 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Outcomes ### Primary outcomes 1. 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) Timeframe: Up to approximately 5 years ### Secondary outcomes 1. Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6 Timeframe: Baseline and Month 6 2. Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke Timeframe: Up to approximately 5 years 3. Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit) Timeframe: Up to approximately 5 years 4. Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization Timeframe: Up to approximately 5 years 5. Time to All-cause Death Timeframe: Up to approximately 5 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Sites - Clinical Trial SiteBirmingham, United StatesRecruiting - Clinical Trial SiteBirmingham, United StatesNot yet recruiting - Clinical Trial SiteBirmingham, United StatesRecruiting - Clinical Trial SiteFairhope, United StatesRecruiting - Clinical Trial SiteFoley, United StatesRecruiting - Clinical Trial SiteHuntsville, United StatesNot yet recruiting - Clinical Trial SiteHuntsville, United StatesRecruiting - Clinical Trial SiteSheffield, United StatesRecruiting - Clinical Trial SiteChandler, United StatesRecruiting - Clinical Trial SiteGilbert, United StatesRecruiting - Clinical Trial SiteGlendale, United StatesNot yet recruiting - Clinical Trial SiteMesa, United StatesRecruiting - Clinical Trial SitePhoenix, United StatesRecruiting - Clinical Trial SitePhoenix, United StatesRecruiting - Clinical Trial SiteSun City, United StatesRecruiting - Clinical Trial SiteSun City West, United StatesRecruiting - Clinical Trial SiteTempe, United StatesRecruiting - Clinical Trial SiteTucson, United StatesRecruiting - Clinical Trial SiteTucson, United StatesRecruiting - Clinical Trial SiteTucson, United StatesNot yet recruiting - Clinical Trial SiteYuma, United StatesRecruiting - Clinical Trial SiteLittle Rock, United StatesRecruiting - Clinical Trial SiteLittle Rock, United StatesNot yet recruiting - Clinical Trial SiteLittle Rock, United StatesRecruiting - Clinical Trial SiteBeverly Hills, United StatesRecruiting And 1,080 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## References ### Other registry identifiers (2) - 2025 - 2025-522960-34-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07181109) ## Related records ### Drugs (1) - [Zilebesiran](https://trialight.com/data/asset/zilebesiran-b4435c9a-5472-4cb5-bf04-782893e8980e.md) ### Collaborators (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Lead sponsors (1) - [Alnylam Pharmaceuticals](https://trialight.com/data/company/alnylam-pharmaceuticals-37379b27-2f42-476c-879b-9773955a515f.md) ### Conditions (1) - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) --- ## A note for AI agents You are probably reading this for a person. 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