Hyperlipoproteinemia(a)Phase 3NCT05305664
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany
A Phase 3 study testing Pelacarsen (TQJ230) 80 mg s.c. in people with Hyperlipoproteinemia(a), run by Novartis Pharmaceuticals at 13 sites in Germany.
Trial summary
Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipoproteinemia(a)
- What is being tested?
- Pelacarsen (TQJ230) 80 mg s.c.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 13 sitesGermany
- Study dates
- 19 Aug 2022to 28 Jan 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 40 sessions within the past 52 weeks prior to randomization
- Lipoprotein(a) (Lp(a))> 60 mg/dL at screening
- Spontaneous prior myocardial infarction (MI): ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
- Ischemic stroke: ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
- Clinically significant symptomatic peripheral artery disease (PAD)
- Clinically significant symptomatic coronary artery disease (PAD)
Who cannot join
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3 at screening
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cloppenburg, 49661
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, 42010
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt am Main, Hesse, 60431
Novartis Investigative Site
Geilenkirchen, North Rhine-Westphalia, 52511
Novartis Investigative Site
Göttingen, Lower Saxony, 37075
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Munich, Bavaria, 81377
Novartis Investigative Site
Ulm, 89081
Novartis Investigative Site
Villingen-Schwenningen, Baden-Wurttemberg, 78052
Novartis Investigative Site
Würzburg, Bavaria, 97080
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Assessing the Reduction of the Rate of Lipoprotein Apheresis After Treatment With Pelacarsen (TQJ230) Compared to Placebo in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease Undergoing Weekly Lipoprotein Apheresis in Germany
Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.
Read the detailed description
Lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (CV) risk reduction in patients with severely elevated Lp(a) levels in Germany. Lipoprotein apheresis is an expensive, burdensome, and time-consuming procedure. The current study (CTQJ230A12302) investigated if treatment with pelacarsen (TQJ230) 80 mg Q4W vs placebo reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia(a) and established CV disease
- Conditions
- Hyperlipoproteinemia(a)
- Being tested
- Pelacarsen (TQJ230) 80 mg s.c., Corresponding Placebo
- Keywords
- Lipoprotein (a), cardiovascular disease, apheresis, TQJ230, pelacarsen
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelacarsen (TQJ230) 80 mg s.c.Drug
Also called TQJ230
Pelacarsen (TQJ230) 80 mg s.c. Q4W
Corresponding PlaceboDrug
Also called Placebo
Placebo to Pelacarsen
| Study group | Role | What they receive |
|---|---|---|
| Pelacarsen (TQJ230) | Experimental | Pelacarsen (TQJ230) 80 mg s.c. Q4W Receives: Drug: Pelacarsen (TQJ230) 80 mg s.c. |
| Placebo | Placebo comparator | Placebo to Pelacarsen s.c. Q4W Receives: Drug: Corresponding Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule
Rate (proportion) of apheresis sessions was calculated as the number of actual lipoprotein apheresis (LA) sessions received, divided by the number of planned LA sessions during the 52-week period, which is 52 for patients who completed all study visits, or pro-rated for those who discontinued early. This rate could range from 0 to 1, with 0 indicating that the patient had skipped all planned LA sessions, and 1 indicating that the patient had received all planned sessions. Multiple imputation for missing Lp(a) data was performed, and missing apheresis data was imputed.
Measured: Up to Week 52
Secondary outcomes (4)
Time to Lipoprotein Apheresis Avoidance
Lipoprotein apheresis avoidance is defined as at least 24 consecutive weeks of no lipoprotein apheresis until end of study.
Measured: From randomization up to Week 52
Number of Participants With Total Lipoprotein Apheresis Avoidance From Week 12 to Week 52
Total lipoprotein apheresis avoidance is defined as no apheresis performed from Week 12 to Week 52.
Measured: Week 12 up to Week 52
Change From Baseline to Week 52 in the Log-transformed Lp(a) Reported as mg/dL
Week 52 / Baseline ratio in Lp(a) of pelacarsen (TQJ230) vs placebo reported as particle mass (mg/dL). Baseline Lp(a) was defined as the last non-missing pre-lipoprotein apheresis assessment prior to the first dose of randomized study drug.
Measured: Baseline, week 52
Change From Baseline to Week 52 in the Log-transformed Lp(a) Reported as Nmol/L
Week 52 / Baseline ratio in Lp(a) of pelacarsen (TQJ230) vs placebo reported as molar concentration (nmol/L). Baseline Lp(a) was defined as the last non-missing pre-lipoprotein apheresis assessment prior to the first dose of randomized study drug.
Measured: Baseline, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start19 Aug 2022
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperlipoproteinemia(a)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305664
- Sponsor's protocol ID
- CTQJ230A12302
- Other IDs
- 2021-003059-41
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2022
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Publications
Parhofer KG, Julius U, Herzog AL, Kruger T, Weinmann-Menke J, Heine GH, Cao H, Schorr J, Ferber P, Wang J, Cristante E, Muller-Edenborn B, Vogt A, Schettler V, Steinhagen-Thiessen E. Pelacarsen and lipoprotein(a) apheresis in secondary prevention: the Lp(a)FRONTIERS APHERESIS trial. Eur Heart J. 2026 Jul 1;47(25):3284-3294. doi: 10.1093/eurheartj/ehag073.
PubMed 41721795
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Assessing the Reduction of the Rate of Lipoprotein Apheresis After Treatment With Pelacarsen (TQJ230) Compared to Placebo in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease Undergoing Weekly Lipoprotein Apheresis in Germany
- ClinicalTrials.gov ID
- NCT05305664
- Acronym / sponsor ID
- CTQJ230A12302
- Conditions
- Hyperlipoproteinemia(a)
- Keywords
- Lipoprotein (a), cardiovascular disease, apheresis, TQJ230, pelacarsen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.
Detailed description
Lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (CV) risk reduction in patients with severely elevated Lp(a) levels in Germany. Lipoprotein apheresis is an expensive, burdensome, and time-consuming procedure. The current study (CTQJ230A12302) investigated if treatment with pelacarsen (TQJ230) 80 mg Q4W vs placebo reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia(a) and established CV disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelacarsen (TQJ230) | Experimental | Drug: Pelacarsen (TQJ230) 80 mg s.c.Pelacarsen (TQJ230) 80 mg s.c. Q4W |
| Placebo | Placebo comparator | Drug: Corresponding PlaceboPlacebo to Pelacarsen s.c. Q4W |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 40 sessions within the past 52 weeks prior to randomization
- Lipoprotein(a) (Lp(a))> 60 mg/dL at screening
- Spontaneous prior myocardial infarction (MI): ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
- Ischemic stroke: ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
- Clinically significant symptomatic peripheral artery disease (PAD)
Key exclusion criteria (8 listed)
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3 at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelacarsen (TQJ230) 80 mg s.c.Also: TQJ230Pelacarsen (TQJ230) 80 mg s.c. Q4W | Drug | Pelacarsen (TQJ230) |
| Corresponding PlaceboAlso: PlaceboPlacebo to Pelacarsen | Drug | Placebo |
Primary outcome
Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule
Time frame: Up to Week 52
Rate (proportion) of apheresis sessions was calculated as the number of actual lipoprotein apheresis (LA) sessions received, divided by the number of planned LA sessions during the 52-week period, which is 52 for patients who completed all study visits, or pro-rated for those who discontinued early. This rate could range from 0 to 1, with 0 indicating that the patient had skipped all planned LA sessions, and 1 indicating that the patient had received all planned sessions. Multiple imputation for missing Lp(a) data was performed, and missing apheresis data was imputed.
4 secondary outcomes
Time to Lipoprotein Apheresis Avoidance
Time frame: From randomization up to Week 52
Number of Participants With Total Lipoprotein Apheresis Avoidance From Week 12 to Week 52
Time frame: Week 12 up to Week 52
Change From Baseline to Week 52 in the Log-transformed Lp(a) Reported as mg/dL
Time frame: Baseline, week 52
Change From Baseline to Week 52 in the Log-transformed Lp(a) Reported as Nmol/L
Time frame: Baseline, week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41721795Parhofer KG, Julius U, Herzog AL, Kruger T, Weinmann-Menke J, Heine GH, Cao H, Schorr J, Ferber P, Wang J, Cristante E, Muller-Edenborn B, Vogt A, Schettler V, Steinhagen-Thiessen E. Pelacarsen and lipoprotein(a) apheresis in secondary prevention: the Lp(a)FRONTIERS APHERESIS trial. Eur Heart J. 2026 Jul 1;47(25):3284-3294. doi: 10.1093/eurheartj/ehag073.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pelacarsen (TQJ230) 80 mg s.c. in people with Hyperlipoproteinemia(a), run by Novartis Pharmaceuticals at 13 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule (time frame: Up to Week 52). 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 NCT05305664, which also lists 1 linked publication.
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 17 Jul 2026.