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Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Sponsor: Alnylam Pharmaceuticals
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11000
Start Date
2025-09-06
Completion Date
2030-09-23
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Zilebesiran
Zilebesiran will be administered SC
Placebo
Placebo will be administered SC
Locations (1190)
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Fairhope, Alabama, United States
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Foley, Alabama, United States
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Huntsville, Alabama, United States
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Huntsville, Alabama, United States
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Sheffield, Alabama, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Sun City, Arizona, United States
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Sun City West, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Yuma, Arizona, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Covina, California, United States
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Escondido, California, United States
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Glendale, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Lynwood, California, United States
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Newhall, California, United States
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Northridge, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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San Ramon, California, United States
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Stockton, California, United States
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Tarzana, California, United States
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Toluca Lake, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Vista, California, United States
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Walnut Creek, California, United States
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Wheat Ridge, Colorado, United States
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Bridgeport, Connecticut, United States
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Waterbury, Connecticut, United States
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Boca Raton, Florida, United States
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Brandon, Florida, United States
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Fleming Island, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jensen Beach, Florida, United States
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Leesburg, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Springs, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Wellington, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Brunswick, Georgia, United States
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Canton, Georgia, United States
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Columbus, Georgia, United States
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Columbus, Georgia, United States
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Conyers, Georgia, United States
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Conyers, Georgia, United States
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Fayetteville, Georgia, United States
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Hinesville, Georgia, United States
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Johns Creek, Georgia, United States
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Lawrenceville, Georgia, United States
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Macon, Georgia, United States
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Stonecrest, Georgia, United States
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Suwanee, Georgia, United States
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Thomasville, Georgia, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Hazel Crest, Illinois, United States
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Oak Brook, Illinois, United States
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Orland Park, Illinois, United States
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Peoria, Illinois, United States
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Springfield, Illinois, United States
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Tinley Park, Illinois, United States
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Avon, Indiana, United States
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Carmel, Indiana, United States