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

NCT05646381 · tracked via the Priya Life Science UK tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Started

2024-03-07

Last updated

2026-06-23

Condition(s) studied

Aortic Stenosis

Investigational drug(s) / intervention(s)

Pelacarsen (TQJ230) 80mgMatching placebo

Pelacarsen (TQJ230) 80mg: Pelacarsen (TQJ230) 80mg

Matching placebo: Matching placebo

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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Male and female ≥50 to \<80 years of age at Screening Part II * Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory * Mild or moderate calcific aortic valve stenosis * At the randomization visit, participant must be optimally treated for existing CV risk factors Exclusion Criteria: * Severe calcific aortic valve stenosis * Uncontrolled hypertension * History of malignancy of any organ system * History of hemorrhagic stroke or other major bleeding * Platelet count ≤ LLN * Active liver disease or hepatic dysfunction * Significant kidney disease * Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

Change in peak aortic jet velocity — 36 months
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
Change in aortic valve calcium score — 36 months
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography

Trial sites (140)

Facility	City	Region	Status
Heart Center Research Llc	Huntsville	Alabama	Recruiting
Cardiovascular Res Found	Beverly Hills	California	Recruiting
National Heart Institute	Beverly Hills	California	Recruiting
Flourish Clinical Resrch Covin	Covina	California	Recruiting
Valley Clinical Trials	Northridge	California	Recruiting
Stanford University Medical Center	Palo Alto	California	Recruiting
University Of California San Diego	San Diego	California	Recruiting
UC San Francisco Medical Center	San Francisco	California	Recruiting
Excel Medical Clinical Trials LLC	Boca Raton	Florida	Withdrawn
Nova Clinical Research LLC	Bradenton	Florida	Recruiting
Flourish Res Acq LLC North Miami	Miami	Florida	Recruiting
Inpatient Research Clinical LLC	Miami Lakes	Florida	Recruiting
Advanced Research for Health Improvement LLC	Naples	Florida	Withdrawn
Midwest Heart and Vascular Spec	Overland Park	Kansas	Recruiting
Tufts Medical Center	Boston	Massachusetts	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Brigham and Womens Hosp Harvard Med School	Boston	Massachusetts	Recruiting
Brigham and Womens Hosp Harvard Med School	Boston	Massachusetts	Recruiting
Henry Ford Hospital	Detroit	Michigan	Recruiting
Henry Ford Hospital	Detroit	Michigan	Recruiting
AA Medical Research Center	Flint	Michigan	Recruiting
William Beaumont Hospital	Royal Oak	Michigan	Recruiting
Minneapolis Heart Institute	Minneapolis	Minnesota	Withdrawn
University Of Minnesota	Minneapolis	Minnesota	Recruiting
Overlook Medical Center	Summit	New Jersey	Recruiting
Capital Cardiology Associates	Albany	New York	Recruiting
New York Presbyterian Hospital	New York	New York	Active Not Recruiting
Icahn School of Med at Mt Sinai	New York	New York	Recruiting
Strong Memorial Hospital	Rochester	New York	Recruiting
Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	Recruiting
Lindner Ctr At The Christ Hosp	Cincinnati	Ohio	Recruiting
Ohio State University	Columbus	Ohio	Withdrawn
Perelman School of Medicine	Philadelphia	Pennsylvania	Recruiting
Texas Heart Institute	Houston	Texas	Recruiting
Orion Medical	Houston	Texas	Recruiting
Virginia Heart	Falls Church	Virginia	Recruiting
Carient Heart and Vascular	Manassas	Virginia	Recruiting
Novartis Investigative Site	Innsbruck	Tyrol	Recruiting
Novartis Investigative Site	Linz	Austria	Withdrawn

+ 100 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05646381 on ClinicalTrials.gov ↗ ← All trials in the UK