NCT07517263

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,700 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).

Detailed description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).

Conditions

• Cardiovascular Disease and Lipoprotein(a)

Interventions

Type	Name	Description
DRUG	Pelacarsen (TQJ230)	pelacarsen 80mg s.c. monthly

Timeline

• Start date: 2026-04-13
• Primary completion: 2030-01-09
• Completion: 2030-01-09
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

72 sites across 17 countries: United States, Argentina, Belgium, Brazil, Colombia, Czechia, Germany, India, Israel, Italy, Netherlands, Romania, Slovakia, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study