A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Last updated: June 19, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Congestive Heart Failure

Heart Defect

Treatment

Pelacarsen (TQJ230) 80mg

Matching placebo

Clinical Study ID

NCT05646381
CTQJ230A12203
  • Ages 50-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female ≥50 to <80 years of age at Screening Part II

  • Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory

  • Mild or moderate calcific aortic valve stenosis

  • At the randomization visit, participant must be optimally treated for existing CVrisk factors

Exclusion

Exclusion Criteria:

  • Severe calcific aortic valve stenosis

  • Uncontrolled hypertension

  • History of malignancy of any organ system

  • History of hemorrhagic stroke or other major bleeding

  • Platelet count ≤ LLN

  • Active liver disease or hepatic dysfunction

  • Significant kidney disease

  • Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 502
Treatment Group(s): 2
Primary Treatment: Pelacarsen (TQJ230) 80mg
Phase: 2
Study Start date:
March 07, 2024
Estimated Completion Date:
March 12, 2030

Connect with a study center

  • Novartis Investigative Site

    Innsbruck, Tyrol 6020
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Linz, 4021
    Austria

    Site Not Available

  • Novartis Investigative Site

    Vienna, A 1090
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Vienna 2761369, 1190
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Wien, 1190
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Genk, Limburg 3600
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Yvoir, Namur 5530
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Aalst, Oost Vlaanderen 9300
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Kortrijk, West-Vlaanderen 8500
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Aalst 2803448, 9300
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Genk 2797670, 3600
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Kortrijk 2794055, 8500
    Belgium

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  • Novartis Investigative Site

    Roeselare 2787889, 8800
    Belgium

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  • Novartis Investigative Site

    Yvoir 2783385, 5530
    Belgium

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    Cambridge, Ontario N1R 6V6
    Canada

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    North York, Ontario M6B 3H7
    Canada

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    Ottawa, Ontario K1Y 4W7
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    Montreal, Quebec H3T 1E2
    Canada

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  • Novartis Investigative Site

    Québec, Quebec G1V 4G5
    Canada

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  • Novartis Investigative Site

    Montreal 6077243, Quebec 6115047 H1T 1C8
    Canada

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    Hradec Králové, 500 02
    Czechia

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    Jaroměř, 551 01
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    Prague, 150 06
    Czechia

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    Prague 3067696, 128 08
    Czechia

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    Esbjerg, 6700
    Denmark

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    Roskilde, 4000
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    Viborg, 8800
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    Paris, 75013
    France

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    Paris 2988507, 75015
    France

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    Pessac, 33604
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    Poitiers, 86021
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    Rennes, 35033
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    Rennes 2983990, 35000
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    Frankfurt am Main, Hesse 60594
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    Dresden, Saxony 01099
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    Berlin, 13353
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    Bonn, 53105
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    Essen, 45147
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    Hamburg, 20246
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    Hamburg 2911298, 20246
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    Lüneburg, 21339
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    Mannheim, 68165
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    Jerusalem, 9103102
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    Jerusalem 281184, 9112001
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    Nahariya, 2210001
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    Petah Tikva, 4941492
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    Ramat Gan, 5265601
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    Tel Aviv, 6423906
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    Ancona, AN 60126
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    Bergamo, BG 24127
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    Bologna, BO 40138
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    Brescia, BS 25123
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    Caserta, CE 81100
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    Cona, FE 44124
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    Pozzilli, IS 86077
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    Rotterdam, South Holland 3079 DZ
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    Rotterdam 2747891, South Holland 2743698 3079 DZ
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    Nieuwegein, Utrecht 3435 CM
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    Alcabideche, 2755-009
    Portugal

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    Coimbra, 3004-561
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    Coimbra 2740637, 3000-075
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    Vila Nova de Gaia, 4434 502
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    Salamanca 3111108, Castille and León 3336900 37007
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    Cáceres, Extremadura 10003
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    Córdoba, 14004
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    Madrid, 28040
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  • Novartis Investigative Site

    Madrid 3117735, 28034
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  • Novartis Investigative Site

    Salamanca, 37007
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  • Novartis Investigative Site

    Valencia, 46010
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  • Novartis Investigative Site

    Basel, 4031
    Switzerland

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    Geneva, 1211
    Switzerland

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  • Novartis Investigative Site

    Lausanne, 1011
    Switzerland

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  • Novartis Investigative Site

    Lugano, 6900
    Switzerland

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  • Novartis Investigative Site

    Lugano 2659836, 6903
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    Zurich, 8091
    Switzerland

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    Reading, Berkshire RG1 5AN
    United Kingdom

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    Portadown, Nothern Ireland BT63 5QQ
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    Edinburgh, EH16 4SA
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    London 2643743, SE1 7EH
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    Londonderry, BT47 6SB
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    Londonderry 2643736, BT47 1SB
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    Manchester, M23 9LT
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    Middlesbrough, TS4 3BW
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    Norwich, NR4 7UY
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  • Novartis Investigative Site

    Tyne and Wear, NE29 8NH
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  • Heart Center Research Llc

    Huntsville, Alabama 35801
    United States

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  • Heart Center Research Llc .

    Huntsville, Alabama 35801
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  • Cardiovascular Res Found

    Beverly Hills, California 90210
    United States

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  • National Heart Institute

    Beverly Hills, California 90211
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  • Flourish Clinical Resrch Covin

    Covina, California 91723
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  • Valley Clinical Trials

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  • Stanford University Medical Center

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    San Diego, California 92103-8415
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  • UC San Francisco Medical Center

    San Francisco, California 94143
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  • Cardiovascular Res Found

    Beverly Hills 5328041, California 5332921 90210
    United States

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  • Foothill Cardiology

    Covina 5340175, California 5332921 91723
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  • UC San Francisco Medical Center

    San Francisco 5391959, California 5332921 94143
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  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida 33434
    United States

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  • Nova Clinical Research LLC

    Bradenton, Florida 34209
    United States

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  • Flourish Res Acq LLC North Miami

    Miami, Florida 33138
    United States

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  • Inpatient Research Clinical LLC

    Miami Lakes, Florida 33014
    United States

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  • Advanced Research for Health Improvement LLC

    Naples, Florida 34102
    United States

    Site Not Available

  • Midwest Heart and Vascular Spec

    Overland Park, Kansas 66211
    United States

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  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts 02115
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  • Brigham and Womens Hosp Harvard Med School .

    Boston, Massachusetts 02115
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  • Massachusetts General Hospital

    Boston, Massachusetts 02114
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  • Massachusetts General Hospital Massachusetts General Hospital

    Boston, Massachusetts 02114
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  • Tufts Medical Center

    Boston, Massachusetts 02111
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  • Brigham and Womens Hosp Harvard Med School

    Boston 4930956, Massachusetts 6254926 02115
    United States

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  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

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  • Tufts Medical Center

    Boston 4930956, Massachusetts 6254926 02111
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  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

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  • AA Medical Research Center

    Flint, Michigan 48504
    United States

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  • William Beaumont Hospital

    Royal Oak, Michigan 48073-4192
    United States

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  • Henry Ford Hospital

    Detroit 4990729, Michigan 5001836 48202
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  • Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

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  • University Of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Minneapolis Heart Institute

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Site Not Available

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Active - Recruiting

  • Capital Cardiology Associates

    Albany, New York 12211
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  • Icahn School of Med at Mt Sinai

    New York, New York 10029
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  • New York Presbyterian Hospital

    New York, New York 10021
    United States

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    New York, New York 10021
    United States

    Active - Recruiting

  • Strong Memorial Hospital

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Icahn School of Med at Mt Sinai

    New York 5128581, New York 5128638 10029
    United States

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  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157
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  • Wake Forest University Baptist Medical Center Wake Forest

    Winston-Salem, North Carolina 27157
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  • Carl and Edyth Lindner Ctr for Resch and Ed at The Christ Hosp

    Cincinnati, Ohio 45219
    United States

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  • Lindner Ctr At The Christ Hosp

    Cincinnati, Ohio 45219
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    Columbus, Ohio 43210
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    Columbus, Ohio 43210
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    Philadelphia, Pennsylvania 19104
    United States

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  • Orion Medical

    Houston, Texas 77034
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  • Texas Heart Institute

    Houston, Texas 77030
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    Falls Church, Virginia 22042
    United States

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  • Carient Heart and Vascular

    Manassas, Virginia 20109
    United States

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