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Looking for participantsPhase3

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT07517263

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pelacarsen (TQJ230) (drug)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
Pelacarsen (TQJ230) — drug: pelacarsen 80mg s.c.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 100 Years
Who
All
Number of participants
5,700
Started
2026-05-11
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiovascular disease and lipoprotein(a)
  • • Phase3 - 5,700 participants
  • • This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301)

Who can take part?

  • • Ages 18 Years to 100 Years
  • • Diagnosed with cardiovascular disease and lipoprotein(a)

Where?

  • • Dorchester - Novartis Investigative Site
  • • London - Novartis Investigative Site
  • • London - Novartis Investigative Site
  • • Preston - Novartis Investigative Site
  • • +32 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).

More detail

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).

Cardiovascular Disease and Lipoprotein(a)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 100 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants who have provided agreement to take part prior to initiation of any study-specific activities/procedures.
  • ✓Participants who have completed the parent study EOS visit while still on assigned the the study treatment.

Who cannot take part

  • ✗Participants who for any reason permanently discontinued or have interrupted the the the study treatment for...
  • ✗Participants are receiving another investigational drug or device before the everyone knows which treatment they get treatment period.
  • ✗Participants have a known sensitivity to the the study treatment and are deemed as unsuited for the study by the Investigator...
  • ✗Other protocol-defined inclusion/exclusion criteria may apply.
See the full criteria
Inclusion Criteria: * Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. * Participants who have completed the parent study EOS visit while still on assigned investigational product. Exclusion Criteria: * Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study. * Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5. * Participants are receiving another investigational drug or device before the open-label treatment period. * Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit. Other protocol-defined inclusion/exclusion criteria may apply.

Where Is This Study? (36 UK sites)

Novartis Investigative Site

Dorchester DT1 2JY, United Kingdom

Recruiting

Novartis Investigative Site

London EC1M 6BQ, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

London EN3 4GS, United Kingdom

Recruiting

Novartis Investigative Site

Preston PR2 9QB, United Kingdom

Recruiting

Novartis Investigative Site

Harrow HA1 3UJ, United Kingdom

Recruiting

Novartis Investigative Site

Rochdale OL11 4AU, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Portadown BT63 5QQ, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Taunton TA1 5DA, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chertsey KT16 0PZ, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Newcastle upon Tyne NE7 7DN, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sunderland SR4 7TP, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Cardiff CF5 4AD, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chichester PO19 6SE, United Kingdom

Recruiting

Novartis Investigative Site

Birmingham B9 5SS, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bristol BS2 8HW, United Kingdom

Recruiting

Novartis Investigative Site

Bromwich B71 4HJ, United Kingdom

Recruiting

Novartis Investigative Site

Cardiff CF64 2XX, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chesterfield S40 4AA, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Edinburgh EH16 4SA, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Glasgow G20 7BE, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Leicester LE3 9QP, United Kingdom

Recruiting

Novartis Investigative Site

Liverpool L7 8XP, United Kingdom

Recruiting

Novartis Investigative Site

London W12 0HS, United Kingdom

Recruiting

Novartis Investigative Site

Londonderry BT47 6SB, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Manchester M13 9WL, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Middlesbrough TS4 3BW, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Middlesex UB9 6JH, United Kingdom

Recruiting

Novartis Investigative Site

Newport NP20 2UB, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Norwich NR4 7UY, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Plymouth PL6 8DH, United Kingdom

Recruiting

Novartis Investigative Site

Rhyl LL18 5UJ, United Kingdom

Recruiting

Novartis Investigative Site

Sheffield S5 7AU, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Swansea SA2 8QA, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Tyne and Wear NE29 8NH, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Wiltshire SN15 2SB, United Kingdom

Recruiting

Novartis Investigative Site

Wrexham LL13 7TD, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-09