Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Denmark / NCT05646381
Recruiting Phase 2

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 Denmark 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) 80mg →Matching 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
No
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)

FacilityCityRegionStatus
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.

More Novartis Pharmaceuticals trials in Denmark

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors Recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients Active, not recruiting

Other trials for the same condition

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock Recruiting
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. Active, not recruiting
Angiotensin Receptor Blockers in Aortic Stenosis Recruiting
Quality of Life After Transcatheter Aortic Valve Implantation Active, not recruiting
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 Denmark