Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
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.
- EligibilityCriteria: 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 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult