The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
340
Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.
Change in log transformed lipoprotein A (Lp(a)) concentration
To evaluate the efficacy of Pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C
Time frame: Baseline, 6 Months
Proportion of participants achieving reduction in Lp(a) levels at Month 6
Efficacy of pelacarsen versus placebo in reducing Lp(a)
Time frame: Baseline, Month 6
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
The TEAEs will be defined as any recorded AE with start date located in the on-treatment period. To understand the effect of pelacarsen versus placebo on safety and tolerability in participants treated with background inclisiran. Incidence and severity of AEs by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs.
Time frame: 16 Months
Incidence of treatment emergent adverse events of special interest (AESI)
To understand the effect of pelacarsen versus placebo on safety and tolerability in participants treated with background inclisiran
Time frame: 12 Months
Incidence of study and treatment discontinuations due to TEAEs
Incidence proportion of study discontinuations due to TEAEs
Time frame: 12 Months
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