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

Last updated: February 13, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Treatment

Corresponding Placebo

Pelacarsen (TQJ230) 80 mg s.c.

Clinical Study ID

NCT05305664
CTQJ230A12302
2021-003059-41
  • Ages 18-80
  • All Genders

Study 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 schedule.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weeklyschedule in Germany for ≥ 12 months prior to screening with at least 40 sessionswithin 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 thescreening visit, and/or

  • Clinically significant symptomatic peripheral artery disease (PAD)

Exclusion

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

Study Design

Total Participants: 51
Treatment Group(s): 2
Primary Treatment: Corresponding Placebo
Phase: 3
Study Start date:
August 19, 2022
Estimated Completion Date:
January 28, 2025

Study 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) will investigate 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

Connect with a study center

  • Novartis Investigative Site

    Duesseldorf, North Rhine-Westphalia 42010
    Germany

    Site Not Available

  • Novartis Investigative Site

    Geilenkirchen, North Rhine-Westphalia 52511
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cloppenburg, 49661
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60431
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gottingen, 37075
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81377
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Site Not Available

  • Novartis Investigative Site

    Villingen-Schwenningen, D78052
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97080
    Germany

    Site Not Available

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