NCT06875973 · Novartis Pharmaceuticals
Pelacarsen Roll-over Extension Program
What this study is about
This non-randomly assigned, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the where neither patients nor doctors know which treatment is given parent studies (CTQJ230A12303 or CTQJ230A12304).
View original scientific description
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).
Interventions
DRUG
Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Primary outcome measures
Incidence of Adverse events (AEs) or serious adverse events (SAEs)
Time frame: Up to 48 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Beverly Hills, California
- Canoga Park, California
- Covina, California
- Garden Grove, California
- Irvine, California
- Long Beach, California
- Los Angeles, California
- Northridge, California
- Stanford, California
- Boca Raton, Florida
And 56 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations