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

Aortic Stenosis

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    50 to 80

Participation Criteria

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 CV risk factors

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 Location

Novartis Investigative Site
Novartis Investigative Site
Montreal, Quebec
Canada

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Novartis Investigative Site
Novartis Investigative Site
Montreal, Quebec
Canada

Contact Study Team

Novartis Investigative Site
Novartis Investigative Site
North York, Ontario
Canada

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Novartis Investigative Site
Novartis Investigative Site
Sainte Foy, Quebec
Canada

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Novartis Investigative Site
Novartis Investigative Site
Ottawa, Ontario
Canada

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Study Sponsored By
Novartis
Participants Required
More Information
Study ID: NCT05646381