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Also known as pelacarsen, Pelacarsen (TQJ230)
TQJ230 · 8 trials · 7 indications
Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.
Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study
To evaluate the efficacy of Pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C
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.
Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study
Duration of drug exposure will be collected
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)
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography
The maximum (peak) observed drug concentration in after single-dose administration (mass x volume-1). To assess the PK properties of plasma pelacarsen after a single s.c. injection in participants with mild HI (Child-Pugh classification) as compared to matched healthy participants with normal hepatic function.
The area under the concentration-time curve (AUC) from time zero to the last measurable concentration sampling time (mass x time x volume-1). To assess the PK properties of plasma pelacarsen after a single s.c. injection in participants with mild HI (Child-Pugh classification) as compared to matched healthy participants with normal hepatic function.
The AUC from time zero to infinity (mass x time x volume-1). To assess the PK properties of plasma pelacarsen after a single s.c. injection in participants with mild HI (Child-Pugh classification) as compared to matched healthy participants with normal hepatic function.
| Arm | Type | Description |
|---|---|---|
| Pelacarsen (TQJ230) | EXPERIMENTAL | open-label pelacarsen 80mg |
| Pelacarsen | ACTIVE_COMPARATOR | Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period. |
| TQJ230 | EXPERIMENTAL | TQJ230 80mg QM s.c. |
| Pelacarsen (TQJ230) 80mg | EXPERIMENTAL | Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously |
| Matching placebo | PLACEBO_COMPARATOR | Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously |
| Mild hepatic impairment patients | EXPERIMENTAL | Participants with mild hepatic impairment |
| Healthy participants | EXPERIMENTAL | Matched healthy participants with normal hepatic function |
| Name | Type | Description |
|---|---|---|
| Pelacarsen (TQJ230) | DRUG | pelacarsen 80mg s.c. monthly |
| Pelacarsen | DRUG | Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection. |
| Placebo | DRUG | Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection. |
| Inclisiran | DRUG | All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11. |
| TQJ230 | DRUG | TQJ230 80mg QM s.c. |
| Pelacarsen (TQJ230) 80mg | DRUG | Pelacarsen (TQJ230) 80mg |
| Matching placebo | DRUG | Matching placebo |
Inclusion Criteria: * Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. * Participants who have completed the parent study EOS visit while still on assigned investigational product. Exclusion Criteria: * Participants who for any reaso...
TQJ230 is an investigational RNA therapy developed by Novartis AG for cardiovascular disease. It is designed to lower lipoprotein(a), often called Lp(a), in patients with elevated Lp(a) and established atherosclerotic cardiovascular disease. It is being studied in Phase 3 clinical trials and is not yet approved.
TQJ230 is being developed to treat elevated lipoprotein(a), or Lp(a), in patients with established atherosclerotic cardiovascular disease. The goal is to lower Lp(a) levels and reduce major cardiovascular events in this patient population. It remains investigational and is not approved for use.
TQJ230 targets lipoprotein(a), also known as Lp(a), a lipoprotein particle associated with cardiovascular risk. By targeting Lp(a), the RNA therapy aims to reduce its circulating levels in patients with elevated Lp(a) and established atherosclerotic cardiovascular disease.
TQJ230 is developed by Novartis AG, which trades under the ticker NVS. Novartis is running the Phase 3 clinical program evaluating the RNA therapy in patients with elevated lipoprotein(a) and established atherosclerotic cardiovascular disease.
TQJ230 is in Phase 3 clinical development. It is an investigational RNA therapy and has not been approved by the FDA. The Phase 3 program includes a completed cardiovascular outcomes trial and a completed study in US Black/African American and Hispanic participants.
TQJ230 has been studied in two Phase 3 trials. NCT04023552 assessed lipoprotein(a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with cardiovascular disease, enrolling 8,323 participants. NCT06267560 studied Lp(a) lowering in US Black/African American and Hispanic participants with elevated Lp(a) and established ASCVD, enrolling 422 participants. Both are completed.
Yes, TQJ230 is also known as pelacarsen. Both names refer to the same investigational RNA therapy developed by Novartis AG that targets lipoprotein(a) for patients with elevated Lp(a) and established atherosclerotic cardiovascular disease.