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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 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.

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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).

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

FieldValue
Enrollment Target 340 participants
Start Date 2025-04-30
Est. Completion 2028-02-29
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT06813911

The ClinicalTrials.gov registry entry for NCT06813911 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,468-participant average among 4 other Atherosclerotic Cardiovascular Disease (ASCVD) trials with a reported enrollment target (96% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.