Clinical Trial

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

Study acronym: ZENITH
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
notable Trial sites expanded: 856 -> 995 locations 2026-07-11
notable Trial sites expanded: 742 -> 856 locations 2026-06-13
notable Trial sites expanded: 597 -> 742 locations 2026-05-15
notable Trial sites expanded: 229 -> 597 locations 2026-04-18
Trial Details
NCT Number NCT07181109
Lead Sponsor Alnylam Pharmaceuticals
Collaborators: Hoffmann-La Roche
Conditions High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
Enrollment 11,000 participants
Start Date 2025-09-22
Primary Completion 2030-09-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-13