Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).

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