A Phase 3 interventional study of Pelacarsen (TQJ230) in Cardiovascular Disease and Lipoprotein(a), sponsored by Novartis Pharmaceuticals. Active, not recruiting at 646 sites in 40 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.
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).
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 5,700 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
open-label pelacarsen 80mg
Drug: Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Also known as: TQJ230
Number of participants with Adverse events
Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.
Time frame: Up to 36 months
Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the parent study will be presented
Time frame: Up to 36 months
Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the OLE study will be presented
Time frame: Up to 36 months
Cumulative number of 4P-MACE over time from OLE study baseline
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the OLE study will be presented
Time frame: Up to 36 months
Cumulative number of 4P-MACE over time from parent study baseline
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the parent study will be presented
Time frame: Up to 36 months
Observed value of Lipoprotein(a) (Lp(a))
Samples for Lp(a) assessment will be collected at the defined time points, analyzed and values reported.
Time frame: Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the OLE study
Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the OLE study.
Time frame: Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the parent study
Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the parent study.
Time frame: Baseline, Month 3, Month 12, Month 24, Month 36
Showing the first 100 of 646 sites across 40 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pelacarsen