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

Last updated: May 2, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Heart Defect

Congestive Heart Failure

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

  • 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

    Active - Recruiting

  • Novartis Investigative Site

    Wien, A 1090
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Genk, 3600
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Yvoir, 5530
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    North York, Ontario M6B 3H7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Montreal, Quebec H1T 1C8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Sainte Foy, Quebec G1V 4G5
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Praha 4, Czech Republic 140 21
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Hradec Kralove, 500 02
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Jaromer Budova Polikliniky, 551 01
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Prague 2, 128 08
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Prague 4, 146 24
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Praha, 12808
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Esbjerg, DK-6700
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Hvidovre, 2650
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Roskilde, 4000
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Viborg, 8800
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Paris, 75013
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris 13, 75651
    France

    Site Not Available

  • Novartis Investigative Site

    Pessac, 33604
    France

    Active - Recruiting

  • Novartis Investigative Site

    Pessac Cedex, 33604
    France

    Site Not Available

  • Novartis Investigative Site

    Poitiers, 86021
    France

    Active - Recruiting

  • Novartis Investigative Site

    Rennes, 35033
    France

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt Am Main, Hessen 60594
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dresden, Sachsen 01099
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt, 60594
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Lueneburg, 21339
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 80636
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Oldenburg, 26133
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Beer Sheva, 8457108
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Beer-Sheva, 8457108
    Israel

    Site Not Available

  • Novartis Investigative Site

    Haifa, 3339419
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Nahariya, 22100
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Petach Tikva, 4941492
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Ancona, AN 60126
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Torrette Ancona, AN 60126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bergamo, BG 24127
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Bologna, BO 40138
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Brescia, BS 25123
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Caserta, CE 81100
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Cona, FE 44100
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Pozzilli, IS 86077
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Milano, MI 20138
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Padova, PD 35128
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Amsterdam, 1090 HM
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Rotterdam, 3079 DZ
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Coimbra, 3000 075
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Vila Nova De Gaia, 4434 502
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Salamanca, Castilla Y Leon 37007
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Caceres, Extremadura 10003
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Geneve 14, 1211
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Lugano, 6903
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Zuerich, 8091
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Edinburgh, ED16 4SA
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Leicester, LE3 9QP
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    London, EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Londonderry, BT47 1SB
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Middlesbrough, TS4 3BW
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Tyne And Wear, NE29 8NH
    United Kingdom

    Active - Recruiting

  • Heart Center Research Llc

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Heart Center Research Llc .

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Cardiovascular Res Found

    Beverly Hills, California 90210
    United States

    Active - Recruiting

  • National Heart Institute

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Valley Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • University Of California San Diego

    San Diego, California 92103-8415
    United States

    Active - Recruiting

  • UC San Francisco Medical Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Advanced Research for Health Improvement LLC

    Naples, Florida 34102
    United States

    Active - Recruiting

  • Midwest Heart and Vascular Spec

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Brigham and Womens Hosp Harvard Med School .

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan 48073-4192
    United States

    Active - Recruiting

  • Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • University Of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Active - Recruiting

  • Icahn School of Med at Mt Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • New York Presbyterian Hospital

    New York, New York 10021
    United States

    Active - Recruiting

  • New York Presbyterian Hospital Weill Cornell Med Ctr

    New York, New York 10021
    United States

    Active - Recruiting

  • Strong Memorial Hospital

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Wake Forest University Baptist Medical Center Wake Forest

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Carl and Edyth Lindner Ctr for Resch and Ed at The Christ Hosp

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Ohio State University Heart and Vascular Res Org

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Perelman School of Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Virginia Heart

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Carient Heart and Vascular

    Manassas, Virginia 20109
    United States

    Active - Recruiting

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