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

Completed · Phase 3 · Has a placebo group

Conditions studied: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT06267560

Run by

Novartis Pharmaceuticals

People needed

422

Starts

2024-04-24

Expected to finish

2026-03-25

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):

You may not qualify if…

• 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

Where it is running

• Cardiology and Medicine Clinic PA — Little Rock, Arkansas, United States
• National Heart Institute — Beverly Hills, California, United States
• Alliance Clinical — Canoga Park, California, United States
• Valley Clinical Trials Inc — Covina, California, United States
• NICRs Research Center — Garden Grove, California, United States
• University of Calif Irvine Med Cntr — Irvine, California, United States
• Long Beach Clinical Trials — Long Beach, California, United States
• Angel City Research Inc — Los Angeles, California, United States
• California Medical Research Associates Inc — Northridge, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Acclaim Clinical Research — San Diego, California, United States
• Excel Medical Clinical Trials LLC — Boca Raton, Florida, United States
• C and A Clinical Trials — Cape Coral, Florida, United States
• Proactive Clinical Research — Fort Lauderdale, Florida, United States
• National Research Institute — Hialeah, Florida, United States
• Sister Life Research Inc — Hialeah, Florida, United States
• Zenith Clinical Research — Hollywood, Florida, United States
• Columbus Clinical Services LLC — Miami, Florida, United States
• Finlay Medical Research — Miami, Florida, United States
• Infinite Clinical Research — Miami, Florida, United States
• Flourish Research Miami LLC. — Miami, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• Baptist Health South — Miami, Florida, United States
• A&A Research Group Inc — Miami, Florida, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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