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Could a shot every 4 weeks replace weekly blood filtering for High-Risk heart patients?

NCT ID NCT05305664

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests an experimental drug called pelacarsen in people with very high levels of lipoprotein(a), a type of cholesterol linked to heart disease. Participants currently undergo weekly blood-filtering treatments (apheresis) to lower their Lp(a). The trial aims to see if taking pelacarsen as a shot every four weeks can reduce how often they need these sessions. It involves about 50 adults in Germany who have both high Lp(a) and established cardiovascular disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called pelacarsen (TQJ230) given as a shot under the skin every 4 weeks
What this could lead to
If successful, pelacarsen could free people with high Lp(a) from weekly blood-filtering sessions, simplifying their care and reducing treatment burden.
What could go wrong
This is a mid-stage trial with only 51 participants, so results may not apply to everyone. The drug may not work as hoped, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

51 people

The number who actually took part.

Started

Aug 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder hyperlipoproteinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipoproteinemia(A)

Contacts and locations

Locations

  • Novartis Investigative Site

    Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60431, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 42010, Germany

  • Novartis Investigative Site

    Geilenkirchen, North Rhine-Westphalia, 52511, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Cloppenburg, 49661, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

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