Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04023552 | Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD | PHASE3 | ACTIVE NOT_RECRUITING | 8,323 | — | — | Dec 12, 2019 | Jun 30, 2026 | May 6, 2026 | 904 | United States, Argentina +41 |
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 80 mg injected monthly administered subcutaneously |
| Placebo | PLACEBO_COMPARATOR | Monthly subcutaneous injections. |
| Name | Type | Description |
|---|---|---|
| TQJ230 | DRUG | TQJ230 80 mg injected monthly administered subcutaneously |
| Placebo | DRUG | Placebo to match TQJ230 prefilled syringe to be injected subcutaneously |
Key Inclusion Criteria * Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory * Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit * Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to ...