A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

CTQJ230A12303

Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.

2024-05-27

2027-06-21

2027-06-21

Not yet recruiting

Early phase I

400

Inclusion Criteria: * Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age * Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory * On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines. * Established ASCVD disease defined as documented: * Coronary heart disease (CHD) and/or * Cerebrovascular disease (CVD) and/or * Peripheral arterial disease (PAD): Exclusion Criteria: * Uncontrolled hypertension * Heart failure New York Heart Association (NYHA) class IV * History of malignancy of any organ system * History of hemorrhagic stroke or other major bleeding * Platelet count \<140,000 per mm3 * Active liver disease or hepatic dysfunction * Significant kidney disease * Pregnant or nursing women

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2024-02-20