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.
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
Severe calcific aortic valve stenosis
Uncontrolled hypertension
History of malignancy of any organ system
History of hemorrhagic stroke or other major bleeding
Parallel
Pelacarsen (TQJ230) 80mg
DrugPelacarsen (TQJ230) 80mg
Matching placebo
DrugMatching placebo
Change in peak aortic jet velocity
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
Change in aortic valve calcium score
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography
Change in Lp(a) levels
To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
Change in fibrocalcific thickening of the aortic valve
To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT
Time from randomization to first occurrence of composite clinical endpoint event
To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either: 1. Unplanned CAVS related hospital admission 2. Aortic valve intervention 3. Death related to calcific aortic valve stenosis
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