An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
Hyperlipoproteinemia (a)
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 18 years - 100 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 41 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
Study terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint
About the research
This non-randomized, open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.
Read the full description
This study will allow to evaluate a long-term safety and tolerability of pelacarsen (TQJ230) 80 mg QM in patients. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study. The maximum duration of this study is approximately 5 years.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Signed informed consent
- Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement.
Exclusion Criteria:
- Any medical condition(s) that may put the participant at risk in the investigator's opinion
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during dosing and for 16 weeks (= 5 times the terminal half-life) after stopping of study medication
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Pelacarsen (TQJ230)
open-label pelacarsen 80 mg
Drug: Pelacarsen
Pelacarsen DRUG
Pelacarsen 80mg s.c. monthly
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.
Time frame: 60 months
Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study
Duration of drug exposure
Time frame: 60 months
Duration of drug exposure will be collected
Secondary measures
Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5
Time frame: 60 months
Evaluate the long-term effect of pelacarsen on the need for lipoprotein apheresis.
Absolute change in Lp(a) compared to baseline of the parent study.
Time frame: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
Evaluate the long-term effect of pelacarsen on Lp(a) change.
Percentage change in Lp(a) compared to baseline of the parent study.
Time frame: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
Evaluate the long-term effect of pelacarsen on Lp(a) change.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (9)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
9 locations
Novartis Investigative SiteMunich, Bavaria, GermanyStatus unknown
Novartis Investigative SiteWürzburg, Bavaria, GermanyStatus unknown
Novartis Investigative SiteFrankfurt am Main, Hesse, GermanyStatus unknown
Novartis Investigative SiteDresden, Saxony, GermanyStatus unknown
Novartis Investigative SiteBerlin, GermanyStatus unknown
Novartis Investigative SiteCloppenburg, GermanyStatus unknown
Novartis Investigative SiteErlangen, GermanyStatus unknown
Novartis Investigative SiteMainz, GermanyStatus unknown
Novartis Investigative SiteUlm, GermanyStatus unknown
Study team and timeline
- Lead sponsor
- Novartis Pharmaceuticals
- Study start
- Sep 29, 2023 Actual
- Primary completion
- Oct 15, 2026 Actual
- Study completion
- Oct 15, 2026 Actual
- First posted
- Jun 12, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Single Arm, Open Label Extension (OLE), Multicenter Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Patients With Cardiovascular Disease Who Have Successfully Completed the Apheresis Parent Study.
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026