CTQJ230A12305B - Pelacarsen Open-label Roll-over Extension Program
Research type
Research Study
Full title
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
IRAS ID
1013468
Contact name
Ilke Cadosch
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2024-520152-17
Clinicaltrials.gov Identifier
Research summary
This study is designed to evaluate the long-term safety of a medicine called TQJ230 (also known as pelacarsen) in people with atherosclerotic cardiovascular disease (ASCVD) who have high levels of lipoprotein(a) (Lp[a]), a type of fat in the blood that can increase the risk of heart attack and stroke. The study will include participants who have already taken part in previous studies of TQJ230 and allows them to continue receiving the treatment while further data is collected. All participants in this study will receive TQJ230, which works by reducing the production of a protein involved in forming Lp(a), with the aim of lowering Lp(a) levels in the blood.
Approximately 600 participants worldwide are expected to take part. The study involves regular health checks, blood tests, and monitoring for any side effects. Participants will receive TQJ230 as an injection under the skin once a month, either administered by study staff or self-administered where appropriate. Treatment will continue for at least one year and may continue for longer depending on ongoing benefit, availability of the medicine, or study timelines.
The main aim of the study is to better understand the long-term safety of TQJ230 by monitoring any medical problems or side effects experienced by participants over time. Additional objectives include evaluating how Lp(a) levels change during continued treatment. As with all clinical studies, there are potential risks, including side effects that may not yet be fully known. Participants will be closely monitored throughout the study, and results will be shared with participants and the public once the research is complete.REC name
South Central - Oxford B Research Ethics Committee
REC reference
26/SC/0159
Date of REC Opinion
3 Jun 2026
REC opinion
Further Information Favourable Opinion