Testing Pelacarsen for cardiovascular disease and lipoprotein(a)
Official title: An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial
- Phase 3
- 1 group
- Sites in Vancouver, Victoria and 5 more cities
- Recruiting
Interventions
- Medication
Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Canadian Sites (14)
9 of 14 recruiting
- Recruiting
Novartis Investigative Site
Vancouver, British Columbia
- Recruiting
Novartis Investigative Site
Victoria, British Columbia
- Recruiting
Novartis Investigative Site
Victoria, British Columbia
- Recruiting
Novartis Investigative Site
Oakville, Ontario
- Recruiting
Novartis Investigative Site
Toronto, Ontario
- Recruiting
Novartis Investigative Site
Montreal, Quebec
- Recruiting
Novartis Investigative Site
Montreal, Quebec
- Recruiting
Novartis Investigative Site
Montreal, Quebec
- Recruiting
Novartis Investigative Site
Québec, Quebec
- Not currently recruiting
Novartis Investigative Site
Vancouver, British Columbia
- Not currently recruiting
Novartis Investigative Site
Lévis, Quebec
- Not currently recruiting
Novartis Investigative Site
Montreal, Quebec
- Not currently recruiting
Novartis Investigative Site
Québec, Quebec
- Not currently recruiting
Novartis Investigative Site
Québec, Quebec
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants who have provided informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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
- −Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
- −Participants are receiving another investigational drug or device before the open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more → treatment period.
- −Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Pelacarsen (TQJ230).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 100 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 5,700 people.
The study is currently expected to finish around January 2030.
The main measurement is taken over: Up to 36 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with Adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over Up to 36 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07517263 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Pelacarsen (TQJ230)Drug
pelacarsen 80mg s.c. monthly
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 100 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 100 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 36 months.
The study as a whole is currently expected to finish around 2030-01-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 5,700 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 19 locations, including: Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada; Oakville, Ontario, Canada; Toronto, Ontario, Canada; Lévis, Quebec, Canada; Montreal, Quebec, Canada, and 13 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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).
Other Sites (18)
Wayne State University
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
AA Medical Research Center
Flint, Michigan, United States
Western Michigan University
Kalamazoo, Michigan, United States
McLaren Ctr Research Innovation
Petoskey, Michigan, United States
Central Michigan University
Saginaw, Michigan, United States
Metro Health Univ of MI Health
Wyoming, Michigan, United States
Saint Johns Hospital
Maplewood, Minnesota, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Northwell Health
Manhasset, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Icahn School of Med at Mt Sinai
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Northwell Health Physician Peconic
Riverhead, New York, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Medical Center-Cardiovascular Research
Seattle, Washington, United States
Univ of Washington Medical Center
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.