This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
600
pelacarsen 80mg s.c. monthly
Incidence of Adverse events (AEs) or serious adverse events (SAEs)
Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study
Time frame: 36 months
Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study
Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels
Time frame: Baseline of the core study, Month 3, 12, 24, 36, 48
Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study
Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels
Time frame: Baseline of the REP study, Month 3, 12, 24, 36, 48
Novartis Pharmaceuticals
CONTACT
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