Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
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
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change in log-transformed Lp(a) concentration from baseline at week 52
Time frame: Baseline, week 52
Secondary Endpoints
Incidence proportion of study discontinuations due to TEAEs
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest
Eligibility Criteria
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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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