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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Zilebesiran
    Zilebesiran will be administered SC
    Other names:
    • ALN-AGT01
Placebo Comparator
Placebo 		Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.
  • Drug: Placebo
    Placebo will be administered SC

Recruiting Locations

Clinical Trial Site
Huntsville 4068590, Alabama 4829764 35805

Clinical Trial Site
Sheffield 4089536, Alabama 4829764 35660

Clinical Trial Site
Gilbert 5295903, Arizona 5551752 85296

Clinical Trial Site
Phoenix 5308655, Arizona 5551752 85015

Clinical Trial Site
Phoenix 5308655, Arizona 5551752 85020

Clinical Trial Site
Sun City West 5316205, Arizona 5551752 85375

Clinical Trial Site
Tucson 5318313, Arizona 5551752 85741

Clinical Trial Site
Little Rock 4119403, Arkansas 4099753 72204

Clinical Trial Site
Little Rock 4119403, Arkansas 4099753 72205

Clinical Trial Site
Chula Vista 5336899, California 5332921 91910

Clinical Trial Site
Escondido 5346827, California 5332921 92025

Clinical Trial Site
Glendale 5352423, California 5332921 91206

Clinical Trial Site
Long Beach 5367929, California 5332921 90815

Clinical Trial Site
Lynwood 5369367, California 5332921 90262

Clinical Trial Site
Northridge 5377985, California 5332921 91325

Clinical Trial Site
Pasadena 5381396, California 5332921 91105

Clinical Trial Site
San Dimas 5391891, California 5332921 91773

Clinical Trial Site
Tarzana 5401143, California 5332921 91356

Clinical Trial Site
Toluca Lake 13157336, California 5332921 91602

Clinical Trial Site
Vista 5406602, California 5332921 92081

Clinical Trial Site
Walnut Creek 5406990, California 5332921 94598

Clinical Trial Site
Boca Raton 4148411, Florida 4155751 33434

Clinical Trial Site
Brandon 4148757, Florida 4155751 33511

Clinical Trial Site
Hialeah 4158476, Florida 4155751 33012

Clinical Trial Site
Hollywood 4158928, Florida 4155751 33024

Clinical Trial Site
Jacksonville 4160021, Florida 4155751 32205

Clinical Trial Site
Jacksonville 4160021, Florida 4155751 32216

Clinical Trial Site
Leesburg 4161771, Florida 4155751 34748

Clinical Trial Site
Melbourne 4163971, Florida 4155751 32934

Clinical Trial Site
Miami 4164138, Florida 4155751 33134

Clinical Trial Site
Miami 4164138, Florida 4155751 33135

Clinical Trial Site
Miami 4164138, Florida 4155751 33186

Clinical Trial Site
Orlando 4167147, Florida 4155751 32825

Clinical Trial Site
Palm Springs 4167583, Florida 4155751 33406

Clinical Trial Site
Tampa 4174757, Florida 4155751 33615

Clinical Trial Site
Wellington 4177703, Florida 4155751 33449

Clinical Trial Site
Brunswick 4184845, Georgia 4197000 31520

Clinical Trial Site
Conyers 4189213, Georgia 4197000 30012

Clinical Trial Site
Conyers 4189213, Georgia 4197000 30094

Clinical Trial Site
Fayetteville 4194474, Georgia 4197000 30214

Clinical Trial Site
Johns Creek 6331909, Georgia 4197000 30024

Clinical Trial Site
Lawrenceville 4205196, Georgia 4197000 30044

Clinical Trial Site
Hazel Crest 4895416, Illinois 4896861 60429

Clinical Trial Site
Orland Park 4904937, Illinois 4896861 60462

Clinical Trial Site
Tinley Park 4913723, Illinois 4896861 60477

Clinical Trial Site
Evansville 4257227, Indiana 4921868 47714

Clinical Trial Site
South Bend 4926563, Indiana 4921868 46617

Clinical Trial Site
Valparaiso 4927537, Indiana 4921868 46383

Clinical Trial Site
Topeka 4280539, Kansas 4273857 66606

Clinical Trial Site
Wichita 4281730, Kansas 4273857 67214

Clinical Trial Site
Lexington 4297983, Kentucky 6254925 40503

Clinical Trial Site
Lafayette 4330145, Louisiana 4331987 70503

Clinical Trial Site
Opelousas 4336153, Louisiana 4331987 70570

Clinical Trial Site
Shreveport 4341513, Louisiana 4331987 71105

Clinical Trial Site
Zachary 4346788, Louisiana 4331987 70791

Clinical Trial Site
Beltsville 4348353, Maryland 4361885 20705

Clinical Trial Site
Bowie 4349159, Maryland 4361885 20715

Clinical Trial Site
Lanham 4360321, Maryland 4361885 20706

Clinical Trial Site
Flint 4992982, Michigan 5001836 48504

Clinical Trial Site
Southfield 5010636, Michigan 5001836 48075

Clinical Trial Site
Troy 5012639, Michigan 5001836 48085

Clinical Trial Site
Olive Branch 4439869, Mississippi 4436296 38654

Clinical Trial Site
Port Gibson 4442187, Mississippi 4436296 39150

Clinical Trial Site
Kansas City 4393217, Missouri 4398678 64111

Clinical Trial Site
Bridgewater 8299576, New Jersey 5101760 08807

Clinical Trial Site
Albuquerque 5454711, New Mexico 5481136 87106

Clinical Trial Site
New Windsor 5128577, New York 5128638 12553

Clinical Trial Site
Rosedale 5134395, New York 5128638 11422

Clinical Trial Site
The Bronx 5110266, New York 5128638 10461

Clinical Trial Site
Durham 4464368, North Carolina 4482348 27704

Clinical Trial Site
Greenville 4469160, North Carolina 4482348 27834

Clinical Trial Site
High Point 4471025, North Carolina 4482348 27260

Clinical Trial Site
Fargo 5059163, North Dakota 5690763 58104

Clinical Trial Site
Beavercreek 4506008, Ohio 5165418 45431

Clinical Trial Site
Cincinnati 4508722, Ohio 5165418 45212

Clinical Trial Site
Cincinnati 4508722, Ohio 5165418 45219

Clinical Trial Site
Columbus 4509177, Ohio 5165418 43213

Clinical Trial Site
Lima 5160783, Ohio 5165418 45801

Clinical Trial Site
Maumee 5162137, Ohio 5165418 43537

Clinical Trial Site
Camp Hill 5182928, Pennsylvania 6254927 17701

Clinical Trial Site
Horsham 5194302, Pennsylvania 6254927 19044

Clinical Trial Site
Uniontown 4561859, Pennsylvania 6254927 15401

Clinical Trial Site
Greenville 4580543, South Carolina 4597040 29607

Clinical Trial Site
Chattanooga 4612862, Tennessee 4662168 37412

Clinical Trial Site
Knoxville 4634946, Tennessee 4662168 37909

Clinical Trial Site
Arlington 4671240, Texas 4736286 76012

Clinical Trial Site
Austin 4671654, Texas 4736286 78735

Clinical Trial Site
Beaumont 4672989, Texas 4736286 77702

Clinical Trial Site
Duncanville 4687331, Texas 4736286 75137

Clinical Trial Site
Houston 4699066, Texas 4736286 77002

Clinical Trial Site
Houston 4699066, Texas 4736286 77024

Clinical Trial Site
Houston 4699066, Texas 4736286 77025

Clinical Trial Site
Houston 4699066, Texas 4736286 77036

Clinical Trial Site
Houston 4699066, Texas 4736286 77043

Clinical Trial Site
Houston 4699066, Texas 4736286 77061

Clinical Trial Site
Houston 4699066, Texas 4736286 77070

Clinical Trial Site
Katy 4702732, Texas 4736286 77450

Clinical Trial Site
Laredo 4705349, Texas 4736286 78041

Clinical Trial Site
McAllen 4709796, Texas 4736286 78503

Clinical Trial Site
McKinney 4710178, Texas 4736286 75071

Clinical Trial Site
Mesquite 4710826, Texas 4736286 75149

Clinical Trial Site
Missouri City 4711801, Texas 4736286 77459

Clinical Trial Site
Paris 4717560, Texas 4736286 75462

Clinical Trial Site
Plano 4719457, Texas 4736286 75024

Clinical Trial Site
Port Arthur 4720039, Texas 4736286 77642

Clinical Trial Site
San Antonio 4726206, Texas 4736286 78220

Clinical Trial Site
San Antonio 4726206, Texas 4736286 78229

Clinical Trial Site
San Antonio 4726206, Texas 4736286 78231

Clinical Trial Site
Sugar Land 4734825, Texas 4736286 77479

Clinical Trial Site
Waco 4739526, Texas 4736286 76712

Clinical Trial Site
Bountiful 5771826, Utah 5549030 84010

Clinical Trial Site
Bountiful 5771826, Utah 5549030 84025

Clinical Trial Site
Layton 5777107, Utah 5549030 84041

Clinical Trial Site
Danville 4755280, Virginia 6254928 24541

Clinical Trial Site
Newport News 4776024, Virginia 6254928 23606

Clinical Trial Site
Norfolk 4776222, Virginia 6254928 23502

Clinical Trial Site
Richmond 4781708, Virginia 6254928 23219

Clinical Trial Site
Suffolk 4788158, Virginia 6254928 23435

Clinical Trial Site
Winchester 4794120, Virginia 6254928 22601

Clinical Trial Site
Bellevue 5786882, Washington 5815135 98007

More Details

Status
Recruiting
Sponsor
Alnylam Pharmaceuticals

Study Contact

Clinical Trial Information Line
1-877-ALNYLAM
clinicaltrials@alnylam.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.