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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Clinical Trial Site
Huntsville, Alabama, United States
Clinical Trial Site
Huntsville, Alabama, United States
Clinical Trial Site
Sheffield, Alabama, United States
Clinical Trial Site
Chandler, Arizona, United States
Clinical Trial Site
Gilbert, Arizona, United States
Clinical Trial Site
Glendale, Arizona, United States
Clinical Trial Site
Mesa, Arizona, United States
Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Sun City West, Arizona, United States
Start Date
September 22, 2025
Primary Completion Date
September 30, 2030
Completion Date
September 30, 2030
Last Updated
February 20, 2026
11,000
ESTIMATED participants
Zilebesiran
DRUG
Placebo
DRUG
Lead Sponsor
Alnylam Pharmaceuticals
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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