CTQJ230A12301E1 HORIZON OLE
Research type
Research Study
Full title
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
IRAS ID
1011654
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2024-519870-38
Research summary
The purpose of this trial is to learn about the long-term treatment with TQJ230, also called pelacarsen, in people with cardiovascular disease and high levels of lipoprotein (a). This trial will include participants who have already completed the previous trial CTQJ230A12301.
Cardiovascular disease (CVD) is a group of heart or blood vessel diseases in which the blood vessels that carry blood to the heart and other body parts become blocked. High blood levels of lipoprotein (a) [Lp(a)] can increase the chances of heart or blood vessel diseases like heart attack or stroke. TQJ230 is a trial drug that is being studied to reduce Lp(a) levels. It blocks the production of a protein called apolipoprotein (a) [apo(a)], which is required to produce Lp(a) in the body.
Approximately 5,700 adult participants from all sexes and race are expected to join this trial. Based on the results of previous trials, TQJ230 may benefit people with CVD and high levels of Lp(a). This trial will benefit participants by providing TQJ230 after completing the CTQJ230A12301 trial.
There might be medical problems with long term use of TQJ230 that are not yet known or have not been predicted. Participants will be closely monitored by the trial doctors for any such medical problems that may happen during the study.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0257
Date of REC Opinion
30 Sep 2025
REC opinion
Further Information Favourable Opinion