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)
Novartis Pharmaceuticals
Lead sponsor