Phase 3Active, not recruiting

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial

Sponsor
Novartis Pharmaceuticals (Industry)
Enrolment
5,700 planned
Conditions
Cardiovascular Disease and Lipoprotein(a)
Interventions
Pelacarsen (TQJ230)
Ages
adults, older adults
Registry
NCT07517263, CTIS2024-519870-38-00

Full record on ClinicalTrials.gov

From the registry

This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.

Primary outcomes

  • Number of participants with Adverse events

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered