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RECRUITING Phase 3

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

NCT06813911 · View on ClinicalTrials.gov ↗

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

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06813911

The ClinicalTrials.gov registry entry for NCT06813911 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06813911 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06813911?

The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG), Pelacarsen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06813911?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial