NCT06875973

Pelacarsen Roll-over Extension Program

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 599 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).

Detailed description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

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

Timeline

• Start date: 2025-05-19
• Primary completion: 2030-12-08
• Completion: 2030-12-08
• First posted: 2025-03-14
• Last updated: 2026-04-15

Locations

97 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study