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Hyperlipoproteinemia (a)Phase 3OLENCT05900141

An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

A Phase 3 study testing Pelacarsen in people with Hyperlipoproteinemia (a), run by Novartis Pharmaceuticals at 9 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Hyperlipoproteinemia (a)
What is being tested?
Pelacarsen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
9 sitesGermany
Study dates
29 Sep 2023to 24 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement.

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Cloppenburg, 49661

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60431

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

About this study

Official 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.

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 detailed 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.

Being tested
Pelacarsen
Keywords
Lipoprotein(a), Cardiovascular disease, Apheresis, Post trial access, pelacarsen (TQJ230)
Medical subject headings
Hyperlipoproteinemias, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PelacarsenDrug

    Also called TQJ230

    Pelacarsen 80mg s.c. monthly

Study groups in NCT05900141
Study groupRoleWhat they receive
Pelacarsen (TQJ230)Experimentalopen-label pelacarsen 80 mg
Receives: Drug: Pelacarsen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.

    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

    Measured: 60 months

  2. Duration of drug exposure

    Duration of drug exposure will be collected

    Measured: 60 months

Secondary outcomes (3)

  1. Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5

    Evaluate the long-term effect of pelacarsen on the need for lipoprotein apheresis.

    Measured: 60 months

  2. Absolute change in Lp(a) compared to baseline of the parent study.

    Evaluate the long-term effect of pelacarsen on Lp(a) change.

    Measured: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)

  3. Percentage change in Lp(a) compared to baseline of the parent study.

    Evaluate the long-term effect of pelacarsen on Lp(a) change.

    Measured: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start29 Sep 2023
  3. Primary completion24 Aug 2028 (estimated)
  4. Study completion24 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label extension (OLE) study
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05900141
Sponsor's protocol ID
CTQJ230A12302E1
Other IDs
2023-503611-16-00, 2023
Acronym
OLE
Status last verified
Oct 2026
First submitted
2 Jun 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pelacarsen in people with Hyperlipoproteinemia (a), run by Novartis Pharmaceuticals at 9 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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