BENITIONSClinical Trial Intelligence

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 NCT05305664

ConditionHyperlipoproteinemia
PhasePhase 3
SponsorNovartis Pharmaceuticals
StatusCompleted
Enrollment51 participants
InterventionsPelacarsen (TQJ230) 80 mg s.c., Corresponding Placebo
Start dateAug 19, 2022
Completion dateJan 28, 2025
Results postedJul 17, 2026

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.

Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule

Up to Week 52 · Apheresis sessions received per week

Pelacarsen (TQJ230)0.16 Apheresis sessions received per week
Placebo0.93 Apheresis sessions received per week
p-value<0.0001
Odds Ratio (OR)0.006 (95% CI 0.003–0.013)

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