Pelacarsen Roll-over Extension Program

Phase 3

Not yet recruiting

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Drug: Pelacarsen (TQJ230)

• Registration Number: NCT06875973
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-14
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Start: 2025-05-20
• Primary Completion: 2027-12-31
• Study Completion: 2028-01-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
• Participants who have completed the parent study and received the assigned study treatment at the time of its completion

Exclusion Criteria

• Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
• Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
• Participants who are receiving another investigational drug or device before the open-label treatment period
• Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pelacarsen (TQJ230)	Pelacarsen (TQJ230)	open-label pelacarsen 80mg

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse events (AEs) or serious adverse events (SAEs)	36 months	Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study

Secondary Outcome Measures

Name	Time	Method
Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study	Baseline of the core study, Month 3, 12, 24, 36, 48	Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels
Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study	Baseline of the REP study, Month 3, 12, 24, 36, 48	Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels