Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Key Inclusion criteria: * 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 * On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit * Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit * Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit Key Exclusion Criteria: * Prior treatment with inclisiran * Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit * Uncontrolled hypertension at R