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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

Status: Recruiting
Location: See all (229) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
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Huntsville
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Huntsville
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Sheffield
Arkansas
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Little Rock
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Little Rock
Arizona
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Chandler
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Gilbert
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Glendale
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Mesa
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Phoenix
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Phoenix
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Sun City West
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Tucson
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Tucson
California
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Beverly Hills
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Chula Vista
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Escondido
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Glendale
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Lancaster
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Long Beach
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Lynwood
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Newhall
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Northridge
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Pasadena
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San Diego
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San Dimas
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Tarzana
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Toluca Lake
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Vista
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Walnut Creek
Florida
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Boca Raton
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Brandon
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Fleming Island
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Hialeah
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Hollywood
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Jacksonville
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Jacksonville
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Jacksonville
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Leesburg
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Melbourne
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Miami
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Miami
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Miami
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Orlando
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Palm Springs
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Tampa
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Wellington
Georgia
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Brunswick
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Columbus
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Conyers
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Conyers
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Fayetteville
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Johns Creek
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Lawrenceville
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Suwanee
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Thomasville
Illinois
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Hazel Crest
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Oak Brook
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Orland Park
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Tinley Park
Indiana
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Avon
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Evansville
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Greenfield
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South Bend
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Valparaiso
Kansas
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Hutchinson
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Topeka
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Wichita
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Wichita
Kentucky
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Lexington
Louisiana
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Hammond
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Lafayette
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Opelousas
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Shreveport
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Zachary
Maryland
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Baltimore
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Baltimore
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Beltsville
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Bowie
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Lanham
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Rockville
Michigan
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Flint
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Southfield
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Troy
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NOT_YET_RECRUITING
Troy
Minnesota
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Richfield
Missouri
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Kansas City
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NOT_YET_RECRUITING
Kansas City
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St Louis
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NOT_YET_RECRUITING
St Louis
Mississippi
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Jackson
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Olive Branch
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Port Gibson
North Carolina
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Durham
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Greenville
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High Point
North Dakota
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Fargo
Nebraska
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Fremont
New Jersey
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Bridgewater
New Mexico
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Albuquerque
New York
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New Windsor
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North Massapequa
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Rosedale
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The Bronx
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West Seneca
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Westfield
Ohio
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Beavercreek
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Cincinnati
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Cincinnati
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Columbus
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Dayton
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Lima
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Maumee
Oklahoma
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Edmond
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Moore
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Oklahoma City
Pennsylvania
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Camp Hill
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Horsham
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Media
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Uniontown
South Carolina
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Columbia
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Greenville
Tennessee
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Chattanooga
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Chattanooga
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Knoxville
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Knoxville
Texas
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Amarillo
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Arlington
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Arlington
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Austin
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Beaumont
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Carrollton
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Dallas
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Duncanville
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Houston
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Houston
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Houston
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Houston
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Houston
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Houston
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Houston
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Houston
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Humble
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Katy
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Kingwood
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Laredo
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Mcallen
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Mckinney
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Mckinney
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Mesquite
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Missouri City
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Paris
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Plano
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Port Arthur
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San Antonio
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San Antonio
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San Antonio
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San Antonio
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Sherman
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Sugar Land
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Tomball
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Waco
Utah
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Bountiful
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Bountiful
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Layton
Virginia
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Arlington
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Danville
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Newport News
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Norfolk
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Richmond
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Suffolk
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Suffolk
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Winchester
Washington
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Bellevue
Other Locations
Australia
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Castle Hill
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Gosford
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Merewether
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Southport
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Waitara
Canada
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Brampton
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Cambridge
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Etobicoke
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Greenfield Park
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Lévis
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Mirabel
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Mississauga
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Moncton
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Scarborough
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Toronto
Japan
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Chikushino-shi
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Chūōku
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Chūōku
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Fukuoka
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Fukuoka
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Hachiōji
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Hakodate-shi
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Himeji
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Izumi
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Kasuga
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Kita-ku
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Kusatsu
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Minamiku
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Minato
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Nagasaki
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Osaka
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Osaka
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Saku
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Sapporo
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Shinagawa-ku
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NOT_YET_RECRUITING
Tamanashi
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Yokosuka
New Zealand
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Ebdentown
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Hamilton
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Silverdale
United Kingdom
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Birmingham
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NOT_YET_RECRUITING
Birmingham
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NOT_YET_RECRUITING
Bury St Edmunds
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NOT_YET_RECRUITING
Cardiff
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NOT_YET_RECRUITING
Chichester
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Corby
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Glasgow
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Ilford
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Leeds
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Liverpool
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London
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Manchester
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Penzance
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Poole
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Teeside
Contact Information
Primary
Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 11000
Treatments
Experimental: Zilebesiran 300 mg
Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.
Placebo_comparator: Placebo
Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.
Sponsors
Collaborators: Hoffmann-La Roche
Leads: Alnylam Pharmaceuticals

This content was sourced from clinicaltrials.gov