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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-80
SponsorNovartis Pharmaceuticals

About this trial

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

Qualifiers

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 CV risk factors

Disqualifiers

Severe calcific aortic valve stenosis

Uncontrolled hypertension

History of malignancy of any organ system

History of hemorrhagic stroke or other major bleeding

Trial design

Treatments tested in this trial

  • Pelacarsen (TQJ230) 80mg
  • Matching placebo

Treatment groups

502 Participants
are divided into 2 treatment groups

Sponsors and collaborators