Atherosclerotic Cardiovascular Disease, ASCVDNCT07000695
Managed Access Programs for TQJ230, Pelacarsen
A study testing Pelacarsen in people with Atherosclerotic Cardiovascular Disease, ASCVD, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this registration is to list Managed Access Programs (MAPs) related to TQJ230, pelacarsen Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, ASCVD
- What is being tested?
- Pelacarsen
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An independent request was received from a licensed physician.
- The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
- Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
- Managed Access provision is allowed per local laws/regulations.
Who cannot join
None listed.
About this study
The purpose of this registration is to list Managed Access Programs (MAPs) related to TQJ230, pelacarsen
Read the detailed description
CTQJ230A12013M - No longer available - Managed Access Program (MAP) Cohort Treatment Plan (CTQJ230A12013M) to provide access to pelacarsen (TQJ230) for (Atherosclerotic Cardiovascular Disease, ASCVD)
- Being tested
- Pelacarsen
- Keywords
- MAP, Manage Access Program, TQJ230, Pelacarsen, Atherosclerotic Cardiovascular Disease, ASCVD
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelacarsenDrug
Also called TQJ230
Patients receive Pelacarsen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease, ASCVDStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000695
- Sponsor's protocol ID
- CTQJ230A12013M
- Status last verified
- Oct 2026
- First submitted
- 12 May 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Programs for TQJ230, Pelacarsen
- ClinicalTrials.gov ID
- NCT07000695
- Acronym / sponsor ID
- CTQJ230A12013M
- Keywords
- MAP, Manage Access Program, TQJ230, Pelacarsen, Atherosclerotic Cardiovascular Disease, ASCVD
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registration is to list Managed Access Programs (MAPs) related to TQJ230, pelacarsen
Detailed description
CTQJ230A12013M - No longer available - Managed Access Program (MAP) Cohort Treatment Plan (CTQJ230A12013M) to provide access to pelacarsen (TQJ230) for (Atherosclerotic Cardiovascular Disease, ASCVD)
Study design
Who may qualify
- Ages
- 18 to 80 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- An independent request was received from a licensed physician.
- The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelacarsenAlso: TQJ230Patients receive Pelacarsen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pelacarsen in people with Atherosclerotic Cardiovascular Disease, ASCVD, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.