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Active, Not Recruiting

NCT Number: NCT05900141

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

This non-randomized, open-label extension study will provide 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hyperlipoproteinemia (a) Cardiovascular Diseases Dyslipidemias Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Frankfurt am Main, Hesse, Germany

Loading trial locations.

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Pelacarsen

Drug

Pelacarsen 80mg s.c. monthly

Other names: TQJ230

Primary outcomes

  1. 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

  2. Duration of drug exposure

    Time frame: 60 months

    Duration of drug exposure will be collected

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

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.

Acronym: OLE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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