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

NCT06267560

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

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

Interventions: TQJ230, Placebo

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (96)
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Canoga Park, California, United States
  • Covina, California, United States
  • Garden Grove, California, United States
  • Irvine, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Northridge, California, United States
  • Palo Alto, California, United States
  • San Diego, California, United States
  • Boca Raton, Florida, United States
  • Cape Coral, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Hialeah, Florida, United States
  • Hialeah, Florida, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Miramar, Florida, United States
  • Palm Springs, Florida, United States
  • Pembroke Pines, Florida, United States
  • Tampa, Florida, United States
  • + 66 more on CT.gov