drugset / Trial / NCT04023552
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
Timeline
- Start
- 2019-12-12
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Publications
- Byambaa E, Roshanravan B, Berglund L. Lipoprotein(a) and CKD: Insights into New Therapeutic Opportunities. Clin J Am Soc Nephrol. 2025 Dec 2. doi: 10.2215/CJN.0000000968. Online ahead of print.
- Cho L, Nicholls SJ, Nordestgaard BG, Landmesser U, Tsimikas S, Blaha MJ, Leitersdorf E, Lincoff AM, Lesogor A, Manning B, Kozlovski P, Cao H, Wang J, Nissen SE. Design and Rationale of Lp(a)HORIZON Trial: Assessing the Effect of Lipoprotein(a) Lowering With Pelacarsen on Major Cardiovascular Events in Patients With CVD and Elevated Lp(a). Am Heart J. 2025 Sep;287:1-9. doi: 10.1016/j.ahj.2025.03.019. Epub 2025 Apr 2.
- Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
- Burvill A, Watts GF, Norman R, Ademi Z. Early health technology assessment of gene silencing therapies for lowering lipoprotein(a) in the secondary prevention of coronary heart disease. J Clin Lipidol. 2024 Nov-Dec;18(6):e946-e956. doi: 10.1016/j.jacl.2024.08.012. Epub 2024 Aug 31.
- Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
- Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.
- Tsimikas S, Reeves RR, Patel MP. Always Present, But Now Rediscovered: Lp(a) as a Predictor of Long-Term Outcomes in PCI. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2069-2072. doi: 10.1016/j.jcin.2021.08.032. No abstract available.
- Plakogiannis R, Sorbera M, Fischetti B, Chen M. The Role of Antisense Therapies Targeting Lipoprotein(a). J Cardiovasc Pharmacol. 2021 Jul 1;78(1):e5-e11. doi: 10.1097/FJC.0000000000001045.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pelacarsen | Antisense oligonucleotide | 80 mg | Subcutaneous |
Indications
No indication recorded.