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TQJ230 · 2 trials · 2 indications
The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.
Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 70 mg/dL)
Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 90 mg/dL)
| Arm | Type | Description |
|---|---|---|
| TQJ230 | EXPERIMENTAL | TQJ230 80mg QM s.c. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo. |
| Name | Type | Description |
|---|---|---|
| TQJ230 | DRUG | TQJ230 80mg QM s.c. |
| Placebo | DRUG | matching placebo |
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...
TQJ230, also known as pelacarsen, is an investigational small molecule being studied for cardiovascular disease and elevated lipoprotein(a), specifically in patients with elevated Lp(a) and established atherosclerotic cardiovascular disease. It is in Phase 3 clinical development and is not yet approved by the FDA.
TQJ230 targets lipoprotein(a), or Lp(a), a risk factor for cardiovascular disease. By lowering Lp(a) levels, the drug aims to reduce major cardiovascular events in patients with established cardiovascular disease and elevated Lp(a).
TQJ230 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical trials for cardiovascular indications.
TQJ230 is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 3 trials have been completed, including a large study with over 8,000 participants.
TQJ230 has been studied in two Phase 3 trials. The first, NCT04023552, enrolled 8,323 patients with cardiovascular disease and elevated Lp(a) across multiple countries. The second, NCT06267560, enrolled 422 US Black/African American and Hispanic participants with elevated Lp(a) and established atherosclerotic cardiovascular disease.
Yes, TQJ230 is also known as pelacarsen. Both names refer to the same investigational drug developed by Novartis for lowering lipoprotein(a) in patients with cardiovascular disease.