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NCT06267560 · ClinicalTrials.gov registry record · Phase 3
Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
A Phase 3 study of Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 422
- Enrollment target
- 20
- Study locations
NCT06267560: Active Phase 3 study of Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
NCT06267560 is a Phase 3 study of Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 422 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06267560, a Phase 3 study of Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 422 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.
Primary Outcome
The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TQJ230
Study Locations (20)
California
- National Heart Institute - Beverly Hills
- Alliance Clinical - Canoga Park
- Valley Clinical Trials Inc - Covina
- NICRs Research Center - Garden Grove
- University of Calif Irvine Med Cntr - Irvine
- Long Beach Clinical Trials - Long Beach
- Angel City Research Inc - Los Angeles
- Velocity Clinical Trials - Los Angeles
- California Medical Research Associates Inc - Northridge
- Stanford University Medical Center - Palo Alto
- Acclaim Clinical Research - San Diego
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
- C and A Clinical Trials - Cape Coral
- Proactive Clinical Research - Fort Lauderdale
- National Research Institute - Hialeah
- Sister Life Research Inc - Hialeah
- Zenith Clinical Research - Hollywood
Alabama
- Parkway Medical Center - Birmingham
Arizona
- Synexus - Glendale
Arkansas
- Cardiology and Medicine Clinic PA - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What the registry record for NCT06267560 still lists
NCT06267560 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06267560 names 20 study sites across 5 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06267560 about?
NCT06267560 is a clinical study titled "Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD". Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated level...
What is the current status of trial NCT06267560?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 422 participants. The study started on 2024-04-24. Estimated completion is 2026-03-31.
What conditions does trial NCT06267560 study?
This clinical trial studies the following conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease.
What interventions are being tested in trial NCT06267560?
The interventions under investigation include: Placebo (DRUG), TQJ230 (DRUG).
Who is sponsoring clinical trial NCT06267560?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06267560 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06267560's enrollment target sits among peer trials
422 887th of 2000 higher than 1,111 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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