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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003059-41 | EudraCT Number |
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Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.
Lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (CV) risk reduction in patients with severely elevated Lp(a) levels in Germany. Lipoprotein apheresis is an expensive, burdensome, and time-consuming procedure. The current study (CTQJ230A12302) will investigate if treatment with pelacarsen (TQJ230) 80 mg Q4W vs placebo reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia(a) and established CV disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelacarsen (TQJ230) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelacarsen (TQJ230) 80 mg s.c. | Drug | Pelacarsen (TQJ230) 80 mg s.c. Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of lipoprotein apheresis sessions performed over 52 weeks normalized to the weekly lipoprotein apheresis schedule | Demonstrate superiority of pelacarsen (TQJ230) compared to placebo in reducing the rate of lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established CVD during 52 weeks of treatment | Over 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to lipoprotein apheresis avoidance (where lipoprotein apheresis avoidance is defined as at least 24 weeks of no lipoprotein apheresis until end of study) | Demonstrate superiority of pelacarsen (TQJ230) compared to placebo in reducing the time to lipoprotein apheresis avoidance | At least 24 weeks up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of lipoprotein apheresis sessions from week 12 to week 52 and week 24 to week 52 normalized to the weekly lipoprotein apheresis schedule | Evaluate rate of lipoprotein apheresis at defined periods of time | Week 12 to 52, Week 24 to 52 |
| Total avoidance of lipoprotein apheresis between week 24 to week 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Düsseldorf | North Rhine-Westphalia | 42010 | Germany | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41721795 | Derived | Parhofer KG, Julius U, Herzog AL, Kruger T, Weinmann-Menke J, Heine GH, Cao H, Schorr J, Ferber P, Wang J, Cristante E, Muller-Edenborn B, Vogt A, Schettler V, Steinhagen-Thiessen E. Pelacarsen and lipoprotein(a) apheresis in secondary prevention: the Lp(a)FRONTIERS APHERESIS trial. Eur Heart J. 2026 Jul 1;47(25):3284-3294. doi: 10.1093/eurheartj/ehag073. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 16, 2025 | |
| Reset | Jan 6, 2026 | |
| Release | Jun 29, 2026 |
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| Corresponding Placebo | Drug | Placebo to Pelacarsen |
|
|
| Total avoidance of lipoprotein apheresis from week 12 to week 52 |
Demonstrate superiority of pelacarsen (TQJ230) vs placebo in avoiding the performance of any lipoprotein apheresis in the last 40 weeks of the study |
| Week 12 to Week 52 |
| Change from baseline to week 52 in the log-transformed Lp(a) (measured prior to planned lipoprotein apheresis) | Demonstrate superiority of pelacarsen (TQJ230) vs placebo in lowering Lp(a) after 52 weeks | 52 weeks |
Evaluate avoidance of the performance of any lipoprotein apheresis in the last 28 weeks of the study |
| Week 24 to Week 52 |
| Time-averaged Lp(a) levels | Evaluate pre- and post-lipoprotein apheresis Lp(a) levels | 52 weeks |
| Percent change in total cholesterol, LDL-C, High-density lipoprotein-Cholesterol (HDL-C), non-HDL-C, Very-low-density lipoprotein-Cholesterol (VLDL-C), apoB and triglycerides (pre- lipoprotein apheresis) from baseline to week 52 | Evaluate the change in expanded lipid profile parameters | 52 weeks |
| Change from baseline to week 52 in the physical and mental health summary scores for the SF-36 questionnaire and a patient preference questionnaire | Evaluate quality of life | 52 weeks |
| Geilenkirchen |
| North Rhine-Westphalia |
| 52511 |
| Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Cloppenburg | 49661 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Frankfurt | 60431 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Villingen-Schwenningen | D78052 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Reset | Jul 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 16, 2025 | Jan 6, 2026 | |||
| Jun 29, 2026 | Jul 1, 2026 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000730804 | pelacarsen |
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