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NCT05646381 · ClinicalTrials.gov registry record · Phase 2

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

A Phase 2 study of Aortic Stenosis, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
502
Enrollment target
20
Study locations

NCT05646381 is a Phase 2 study of Aortic Stenosis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 502 participants, below the 1,343-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT05646381, a Phase 2 study of Aortic Stenosis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
502 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Conditions Studied

Interventions

  • DRUG Pelacarsen (TQJ230) 80mg
  • DRUG Matching placebo

Study Locations (20)

California

  • Cardiovascular Res Found - Beverly Hills
  • National Heart Institute - Beverly Hills
  • Flourish Clinical Resrch Covin - Covina
  • Valley Clinical Trials - Northridge
  • Stanford University Medical Center - Palo Alto
  • University Of California San Diego - San Diego
  • UC San Francisco Medical Center - San Francisco

Florida

  • Excel Medical Clinical Trials LLC - Boca Raton
  • Nova Clinical Research LLC - Bradenton
  • Flourish Res Acq LLC North Miami - Miami
  • Inpatient Research Clinical LLC - Miami Lakes
  • Advanced Research for Health Improvement LLC - Naples

Massachusetts

  • Tufts Medical Center - Boston
  • Massachusetts General Hospital - Boston
  • Massachusetts General Hospital - Boston
  • Brigham and Womens Hosp Harvard Med School - Boston
  • Brigham and Womens Hosp Harvard Med School - Boston

Alabama

  • Heart Center Research Llc - Huntsville

Kansas

  • Midwest Heart and Vascular Spec - Overland Park

Michigan

  • Henry Ford Hospital - Detroit

Trial Details

FieldValue
Enrollment Target 502 participants
Start Date 2024-03-07
Est. Completion 2030-03-12
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT05646381

The ClinicalTrials.gov registry entry for NCT05646381 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 502 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,343-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (63% 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 Aortic Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Pelacarsen (TQJ230) 80mg is the first listed.

NCT05646381 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05646381 about?

NCT05646381 is a clinical study titled "A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis". The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

What is the current status of trial NCT05646381?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 502 participants. The study started on 2024-03-07. Estimated completion is 2030-03-12.

What conditions does trial NCT05646381 study?

This clinical trial studies the following conditions: Aortic Stenosis.

What interventions are being tested in trial NCT05646381?

The interventions under investigation include: Pelacarsen (TQJ230) 80mg (DRUG), Matching placebo (DRUG).

Who is sponsoring clinical trial NCT05646381?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05646381 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Kansas, Massachusetts. 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.