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

Last updated: December 23, 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 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

    Site Not Available

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    Innsbruck 2775220, Tyrol 2763586 6020
    Austria

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    Linz, 4021
    Austria

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  • Novartis Investigative Site

    Linz 2772400, 4021
    Austria

    Site Not Available

  • Novartis Investigative Site

    Vienna 2761369, 1190
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Wien, A 1090
    Austria

    Site Not Available

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    Genk 2797670, Limburg 3600
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Yvoir 2783385, Namur 5530
    Belgium

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  • Novartis Investigative Site

    Aalst 2803448, Oost Vlaanderen 9300
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Kortrijk 2794055, West-Vlaanderen 8500
    Belgium

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  • Novartis Investigative Site

    Roeselare 2787889, West-Vlaanderen 8800
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    Aalst, 9300
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    Genk, 3600
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    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Carient Heart and Vascular

    Manassas, Virginia 20109
    United States

    Site Not Available

  • Virginia Heart

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Active - Recruiting

  • Carient Heart and Vascular

    Manassas 4771401, Virginia 6254928 20109
    United States

    Active - Recruiting

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