A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany

Phase 3 Completed 51 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2022-08-19
Primary completion: 2025-01-28
Completion: 2025-01-28

Outcome

Met primary endpoint

paper Pelacarsen reduced the mean rates of LA (0.16 vs 0.93 in placebo, odds ratio 0.006, 95% confidence interval [CI] 0.003, 0.013; P < .0001) PMID 41721795 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pelacarsen	Antisense oligonucleotide	80 mg	Subcutaneous