Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)

Last updated: May 15, 2025
Sponsor: Alnylam Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Stress

Circulation Disorders

Williams Syndrome

Treatment

Placebo

Zilebesiran

Clinical Study ID

NCT06272487
ALN-AGT01-007
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of cardiovascular (CV) disease, high CV risk, or estimated glomerularfiltration rate (eGFR) ≥30 to <60 mL/min/1.73m^2

  • Mean seated office SBP ≥140 mmHg and ≤170 mmHg

  • 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM

  • Must be on stable therapy with 2 to 4 classes of antihypertensive medications

Exclusion

Exclusion Criteria:

  • Secondary hypertension

  • Orthostatic hypotension

  • Proteinuria >3 g/day

  • Serum potassium >4.8 milliequivalents per liter (mEq/L)

Study Design

Total Participants: 375
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 29, 2024
Estimated Completion Date:
December 19, 2025

Connect with a study center

  • Clinical Trial Site

    Bruce, Australian Capital Territory
    Australia

    Site Not Available

  • Clinical Trial Site

    Sydney, Australian Capital Territory
    Australia

    Site Not Available

  • Clinical Trial Site

    Brookvale, New South Wales
    Australia

    Site Not Available

  • Clinical Trial Site

    Concord, New South Wales
    Australia

    Site Not Available

  • Clinical Trial Site

    Kanwal, New South Wales
    Australia

    Site Not Available

  • Clinical Trial Site

    Kogarah, New South Wales
    Australia

    Site Not Available

  • Clinical Trial Site

    Sherwood, Queensland
    Australia

    Site Not Available

  • Clinical Trial Site

    Sippy Downs, Queensland
    Australia

    Site Not Available

  • Clinical Trial Site

    Garran,
    Australia

    Site Not Available

  • Clinical Trial Site

    Perth,
    Australia

    Site Not Available

  • Clinical Trial Site

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Clinical Trial Site

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Clinical Trial Site

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Clinical Trial Site

    Toronto, Ontario G1V 4T3
    Canada

    Site Not Available

  • Clinical Trial Site

    Waterloo, Ontario
    Canada

    Site Not Available

  • Clinical Trial Site

    Chicoutimi, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Greenfield Park, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Montreal, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Montréal, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Québec, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Trois Rivieres, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Clinical Trial Site

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Clinical Trial Site

    Ponce, 00959
    Puerto Rico

    Site Not Available

  • Clinical Trial Site

    Basel,
    Switzerland

    Site Not Available

  • Clinical Trial Site

    Geneva,
    Switzerland

    Site Not Available

  • Clinical Trial Site

    Lausanne,
    Switzerland

    Site Not Available

  • Clinical Trial Site

    Luzern, 6000
    Switzerland

    Site Not Available

  • Clinical Trial Site

    Luton, Bedfordshire
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Fowey, Cornwall PL23 1DT
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Liskeard, Cornwall PL14 3XA
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Newquay, Cornwall TR1 3HD
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Torpoint, Cornwall PL11 2JW
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Chesterfield, Derbyshire S40 4AA
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Plymouth, Devon PL5 3JB
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Bristol, Gloucestershire BS2 8ED
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Canterbury, Kent CT1 3NG
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Bellshill, Lanarkshire ML4 3NJ
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Glasgow, Lanarkshire G11 5JT
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Manchester, Lancashire
    United Kingdom

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  • Clinical Trial Site

    Leicester, Leicestershire
    United Kingdom

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  • Clinical Trial Site

    Hexham, Northumberland
    United Kingdom

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  • Clinical Trial Site

    Carshalton, Surrey
    United Kingdom

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  • Clinical Trial Site

    Birmingham,
    United Kingdom

    Site Not Available

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    Cardriff,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Chorley,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Liverpool,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    London, EC1M 6BQ
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Pickering,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Alexander City, Alabama 35010
    United States

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  • Clinical Trial Site

    Daphne, Alabama 36606
    United States

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  • Clinical Trial Site

    Foley, Alabama 36535
    United States

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  • Clinical Trial Site

    Huntsville, Alabama 35801
    United States

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  • Clinical Trial Site

    Montgomery, Alabama 36117
    United States

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  • Clinical Trial Site

    Gilbert, Arizona 85297
    United States

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  • Clinical Trial Site

    Phoenix, Arizona 85028
    United States

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  • Clinical Trial Site

    Sun City, Arizona 85351
    United States

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  • Clinical Trial Site

    Tempe, Arizona 85283
    United States

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  • Clinical Trial Site

    Tucson, Arizona 85741
    United States

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  • Clinical Trial Site

    Beverly Hills, California 90211
    United States

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  • Clinical Trial Site

    Covina, California 91723
    United States

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  • Clinical Trial Site

    Encinitas, California 92024
    United States

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  • Clinical Trial Site

    Garden Grove, California 92844
    United States

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  • Clinical Trial Site

    Huntington Beach, California 92647
    United States

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  • Clinical Trial Site

    Los Angeles, California 90022
    United States

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  • Clinical Trial Site

    Northridge, California 91324
    United States

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  • Clinical Trial Site

    Pasadena, California 91105
    United States

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  • Clinical Trial Site

    San Diego, California 92111
    United States

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  • Clinical Trial Site

    San Dimas, California 91773
    United States

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  • Clinical Trial Site

    Santa Ana, California 90057
    United States

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  • Clinical Trial Site

    Simi Valley, California 93065
    United States

    Site Not Available

  • Clinical Trial Site

    Vacaville, California 95687
    United States

    Site Not Available

  • Clinical Trial Site

    Van Nuys, California 91405
    United States

    Site Not Available

  • Clinical Trial Site

    West Hills, California 91307
    United States

    Site Not Available

  • Clinical Trial Site

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • Clinical Trial Site

    Denver, Colorado 80230
    United States

    Site Not Available

  • Clinical Trial Site

    Hartford, Connecticut 06112
    United States

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  • Clinical Trial Site

    Middlebury, Connecticut 06762
    United States

    Site Not Available

  • Clinical Trial Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Clinical Trial Site

    Washington, District of Columbia 20011
    United States

    Site Not Available

  • Clinical Trial Site

    Clearwater, Florida 33770
    United States

    Site Not Available

  • Clinical Trial Site

    Coral Gables, Florida 89121
    United States

    Site Not Available

  • Clinical Trial Site

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Clinical Trial Site

    Fort Myers, Florida 33901
    United States

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  • Clinical Trial Site

    Hollywood, Florida 33021
    United States

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  • Clinical Trial Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Trial Site

    Jensen Beach, Florida 34957
    United States

    Site Not Available

  • Clinical Trial Site

    Lake City, Florida 32055
    United States

    Site Not Available

  • Clinical Trial Site

    Miami, Florida 33144
    United States

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  • Clinical Trial Site

    North Miami Beach, Florida 33169
    United States

    Site Not Available

  • Clinical Trial Site

    Orlando, Florida 32801
    United States

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  • Clinical Trial Site

    Pembroke Pines, Florida 33027
    United States

    Site Not Available

  • Clinical Trial Site

    The Villages, Florida 32162
    United States

    Site Not Available

  • Clinical Trial Site

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Clinical Trial Site

    Acworth, Georgia 30101
    United States

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  • Clinical Trial Site

    Atlanta, Georgia 30322
    United States

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  • Clinical Trial Site

    Douglasville, Georgia 30134
    United States

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  • Clinical Trial Site

    Gainesville, Georgia 30501
    United States

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  • Clinical Trial Site

    Savannah, Georgia 31406
    United States

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  • Clinical Trial Site

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • Clinical Trial Site

    Boise, Idaho 83706
    United States

    Site Not Available

  • Clinical Trial Site

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Clinical Trial Site

    Elkhart, Indiana 46514
    United States

    Site Not Available

  • Clinical Trial Site

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Clinical Trial Site

    Richmond, Indiana 47374
    United States

    Site Not Available

  • Clinical Trial Site

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Clinical Trial Site

    Newton, Kansas 67114
    United States

    Site Not Available

  • Clinical Trial Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Clinical Trial Site

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Clinical Trial Site

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Clinical Trial Site

    New Orleans, Louisiana 33134
    United States

    Site Not Available

  • Clinical Trial Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Clinical Trial Site

    Springfield, Massachusetts 01089
    United States

    Site Not Available

  • Clinical Trial Site

    Flint, Michigan 48504
    United States

    Site Not Available

  • Clinical Trial Site

    Roseville, Michigan 48066
    United States

    Site Not Available

  • Clinical Trial Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Clinical Trial Site

    Edina, Minnesota 55404
    United States

    Site Not Available

  • Clinical Trial Site

    Minneapolis, Minnesota 55423
    United States

    Site Not Available

  • Clinical Trial Site

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Clinical Trial Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Clinical Trial Site

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Clinical Trial Site

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Clinical Trial Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Clinical Trial Site

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Clinical Trial Site

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Clinical Trial Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Clinical Trial Site

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Clinical Trial Site

    New York, New York 10017
    United States

    Site Not Available

  • Clinical Trial Site

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Clinical Trial Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Clinical Trial Site

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Clinical Trial Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Clinical Trial Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Clinical Trial Site

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Clinical Trial Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Clinical Trial Site

    Columbus, Ohio 31904
    United States

    Site Not Available

  • Clinical Trial Site

    Marion, Ohio 43302
    United States

    Site Not Available

  • Clinical Trial Site

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Clinical Trial Site

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Clinical Trial Site

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Clinical Trial Site

    Camp Hill, Pennsylvania 17074
    United States

    Site Not Available

  • Clinical Trial Site

    Langhorne, Pennsylvania 19047
    United States

    Site Not Available

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Clinical Trial Site

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Clinical Trial Site

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Clinical Trial Site

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Clinical Trial Site

    Chattanooga, Tennessee 37408
    United States

    Site Not Available

  • Clinical Trial Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Clinical Trial Site

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Clinical Trial Site

    Memphis, Tennessee 38671
    United States

    Site Not Available

  • Clinical Trial Site

    Austin, Texas 78744
    United States

    Site Not Available

  • Clinical Trial Site

    Coppell, Texas 75019
    United States

    Site Not Available

  • Clinical Trial Site

    Dallas, Texas 75234
    United States

    Site Not Available

  • Clinical Trial Site

    El Paso, Texas 79936
    United States

    Site Not Available

  • Clinical Trial Site

    Houston, Texas 77081
    United States

    Site Not Available

  • Clinical Trial Site

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Clinical Trial Site

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • Clinical Trial Site

    Sherman, Texas 75092
    United States

    Site Not Available

  • Clinical Trial Site

    Splendora, Texas 77372
    United States

    Site Not Available

  • Clinical Trial Site

    Stephenville, Texas 76401
    United States

    Site Not Available

  • Clinical Trial Site

    Tomball, Texas 77375
    United States

    Site Not Available

  • Clinical Trial Site 1 - Tomball

    Tomball, Texas 77375
    United States

    Site Not Available

  • Clinical Trial Site 2 - Tomball

    Tomball, Texas 77375
    United States

    Site Not Available

  • Clinical Trial Site

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Clinical Trial Site

    Burke, Virginia 22015
    United States

    Site Not Available

  • Clinical Trial Site

    Manassas, Virginia 20109
    United States

    Site Not Available

  • Clinical Trial Site

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Clinical Trial Site

    Wauwatosa, Wisconsin 53227
    United States

    Site Not Available

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