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NCT06813911 · ClinicalTrials.gov registry record · Phase 3
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
A Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 340
- Enrollment target
- 20
- Study locations
NCT06813911: Recruiting Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD), sponsored by Novartis Pharmaceuticals.
NCT06813911 is a Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 340 participants, below the 9,468-participant average among 4 other Atherosclerotic Cardiovascular Disease (ASCVD) trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06813911, a Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 340 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).
Primary Outcome
To evaluate the efficacy of Pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran
- DRUG Pelacarsen
Study Locations (20)
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
- Jacksonville Center for Clinical - Jacksonville
- K2 Medical Research LLC - Maitland
- University of Miami Hospital - Miami
- Miami Cancer Institute at Bapt - Miami
- Inpatient Research Clinical LLC - Miami Lakes
- Inpatient Research Clinical LLC - Miami Lakes
- FXM Clin Res Miramar LLC - Miramar
- Ocala Cardiovascular Research - Ocala
- SEC Clinical Research - Pensacola
- Peace River Cardiovascular Center - Port Charlotte
- FC Site Partners Miami - Winter Park
California
- National Heart Institute - Beverly Hills
- Interv Cardiology Med Grp - West Hills
Indiana
- American Health Network Research Dept - Muncie
- American Health Network Research Dept - Muncie
Alabama
- Parkway Medical Center - Birmingham
Arizona
- Clinical Research Inst of Arizona - Sun City West
Illinois
- Advocate Lutheran General Childrens Hospital - Park Ridge
Louisiana
- Cardiovascular Associates Research - Covington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2025-04-30 |
| Est. Completion | 2028-02-29 |
| Phase | Phase 3 |
What NCT06813911 shows while recruiting
NCT06813911 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 9,468-participant average among 4 other Atherosclerotic Cardiovascular Disease (ASCVD) trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Atherosclerotic Cardiovascular Disease (ASCVD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06813911 names 20 study sites across 7 states, led by Florida, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT06813911 about?
NCT06813911 is a clinical study titled "Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD". The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholestero...
What is the current status of trial NCT06813911?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2025-04-30. Estimated completion is 2028-02-29.
What conditions does trial NCT06813911 study?
This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease (ASCVD).
What interventions are being tested in trial NCT06813911?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG), Pelacarsen (DRUG).
Who is sponsoring clinical trial NCT06813911?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06813911 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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