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).
Male and female participants 18 to ≤80 years of age at Screening visit
Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
Prior treatment with inclisiran
Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
Uncontrolled hypertension at Randomization/Baseline visit
Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
Parallel
Pelacarsen
DrugPelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
Placebo
DrugPlacebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
Inclisiran
DrugAll 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
Proportion of participants achieving reduction in Lp(a) levels at Month 6
Efficacy of pelacarsen versus placebo in reducing Lp(a)
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.
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
Incidence of study and treatment discontinuations due to TEAEs
Incidence proportion of study discontinuations due to TEAEs
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