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

May 28, 2026 updated by: Novartis Pharmaceuticals

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

502

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Withdrawn
        • Novartis Investigative Site
      • Vienna, Austria, A 1090
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, 1190
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, 1100
        • Recruiting
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Novartis Investigative Site
  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Novartis Investigative Site
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • Novartis Investigative Site
    • Oost Vlaanderen
      • Aalst, Oost Vlaanderen, Belgium, 9300
        • Recruiting
        • Novartis Investigative Site
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • Recruiting
        • Novartis Investigative Site
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Recruiting
        • Novartis Investigative Site
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Hradec Králové, Czechia, 500 02
        • Recruiting
        • Novartis Investigative Site
      • Jaroměř, Czechia, 551 01
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 128 08
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 150 06
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 14021
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Novartis Investigative Site
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Novartis Investigative Site
      • Roskilde, Denmark, 4000
        • Recruiting
        • Novartis Investigative Site
      • Viborg, Denmark, 8800
        • Recruiting
        • Novartis Investigative Site
  • France
      • Paris, France, 75015
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75012
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75013
        • Recruiting
        • Novartis Investigative Site
      • Pessac, France, 33604
        • Recruiting
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Recruiting
        • Novartis Investigative Site
      • Rennes, France, 35033
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Ahaus, Germany, 48683
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Bonn, Germany, 53105
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 22763
        • Recruiting
        • Novartis Investigative Site
      • Lüneburg, Germany, 21339
        • Withdrawn
        • Novartis Investigative Site
      • Mannheim, Germany, 68165
        • Recruiting
        • Novartis Investigative Site
      • München, Germany, 80636
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Recruiting
        • Novartis Investigative Site
      • Oldenburg, Germany, 26133
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60594
        • Recruiting
        • Novartis Investigative Site
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Germany, 67655
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01099
        • Recruiting
        • Novartis Investigative Site
      • Leipzig, Saxony, Germany, 04289
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Beersheba, Israel, 8457108
        • Recruiting
        • Novartis Investigative Site
      • Haifa, Israel, 3109601
        • Recruiting
        • Novartis Investigative Site
      • Haifa, Israel, 3104802
        • Recruiting
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Novartis Investigative Site
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Novartis Investigative Site
      • Nahariya, Israel, 2210001
        • Recruiting
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60126
        • Recruiting
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24127
        • Recruiting
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Withdrawn
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Recruiting
        • Novartis Investigative Site
    • CE
      • Caserta, CE, Italy, 81100
        • Recruiting
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44124
        • Recruiting
        • Novartis Investigative Site
    • IS
      • Pozzilli, IS, Italy, 86077
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20162
        • Recruiting
        • Novartis Investigative Site
      • Milan, MI, Italy, 20138
        • Recruiting
        • Novartis Investigative Site
      • Milan, MI, Italy, 20157
        • Recruiting
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Recruiting
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italy, 33170
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Recruiting
        • Novartis Investigative Site
      • Amsterdam, North Holland, Netherlands, 1090 HM
        • Recruiting
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3079 DZ
        • Recruiting
        • Novartis Investigative Site
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Novartis Investigative Site
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Alcabideche, Portugal, 2755-009
        • Recruiting
        • Novartis Investigative Site
      • Braga, Portugal, 4710243
        • Recruiting
        • Novartis Investigative Site
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • Novartis Investigative Site
      • Vila Nova de Gaia, Portugal, 4434 502
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Withdrawn
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46010
        • Recruiting
        • Novartis Investigative Site
    • Extremadura
      • Cáceres, Extremadura, Spain, 10003
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Novartis Investigative Site
      • Geneva, Switzerland, 1211
        • Recruiting
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Novartis Investigative Site
      • Lugano, Switzerland, 6900
        • Recruiting
        • Novartis Investigative Site
      • Zurich, Switzerland, 8091
        • Withdrawn
        • Novartis Investigative Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE3 9QP
        • Recruiting
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L14 3PE
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Novartis Investigative Site
      • Londonderry, United Kingdom, BT47 6SB
        • Recruiting
        • Novartis Investigative Site
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Novartis Investigative Site
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • Novartis Investigative Site
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Novartis Investigative Site
      • Tyne and Wear, United Kingdom, NE29 8NH
        • Recruiting
        • Novartis Investigative Site
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Recruiting
        • Novartis Investigative Site
    • Nothern Ireland
      • Portadown, Nothern Ireland, United Kingdom, BT63 5QQ
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Heart Center Research LLC
        • Principal Investigator:
          • Vernon R Hunter
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Cardiovascular Res Found
        • Principal Investigator:
          • Ronald P Karlsberg
        • Contact:
      • Covina, California, United States, 91723
        • Recruiting
        • Flourish Clinical Resrch Covin
        • Principal Investigator:
          • Fahed Bitar
        • Contact:
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials
        • Principal Investigator:
          • Mehrdad Ariani
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University Medical Center
        • Principal Investigator:
          • Abha Khandelwal
        • Contact:
      • San Diego, California, United States, 92103-8415
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • Anna Narezkina
      • San Francisco, California, United States, 94143
        • Recruiting
        • UC San Francisco Medical Center
        • Principal Investigator:
          • Eveline Stock
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Withdrawn
        • Excel Medical Clinical Trials LLC
      • Bradenton, Florida, United States, 34209
      • Miami, Florida, United States, 33138
        • Recruiting
        • Flourish Res Acq LLC North Miami
        • Contact:
        • Principal Investigator:
          • Rimsky Denis.
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Inpatient Research Clinical LLC
        • Contact:
        • Principal Investigator:
          • Alexis Gutierrez.
      • Naples, Florida, United States, 34102
        • Withdrawn
        • Advanced Research for Health Improvement LLC
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Midwest Heart and Vascular Spec
        • Contact:
        • Principal Investigator:
          • Vasvi Singh.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Michael Honigberg
        • Contact:
      • Boston, Massachusetts, United States, 02111
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Womens Hosp Harvard Med School
        • Principal Investigator:
          • Rhanderson Cardoso
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Khaled Abdul-Nour
        • Contact:
      • Flint, Michigan, United States, 48504
        • Recruiting
        • AA Medical Research Center
        • Contact:
        • Principal Investigator:
          • Ahmed A Arif.
      • Royal Oak, Michigan, United States, 48073-4192
        • Recruiting
        • William Beaumont Hospital
        • Principal Investigator:
          • Joel Skaistis
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Daniel Duprez
        • Contact:
      • Minneapolis, Minnesota, United States, 55407
        • Withdrawn
        • Minneapolis Heart Institute
    • New Jersey
      • Summit, New Jersey, United States, 07901
    • New York
      • Albany, New York, United States, 12211
        • Recruiting
        • Capital Cardiology Associates
        • Contact:
        • Principal Investigator:
          • Lance Sullenberger.
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Med at Mt Sinai
        • Contact:
        • Principal Investigator:
          • Robert Rosenson.
      • New York, New York, United States, 10021
        • Active, not recruiting
        • New York Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • Recruiting
        • Strong Memorial Hospital
        • Principal Investigator:
          • Robert Block
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Lindner Ctr At The Christ Hosp
        • Principal Investigator:
          • Sitaramesh Emani
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Withdrawn
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Virginia Heart
        • Principal Investigator:
          • Tariq Haddad
        • Contact:
      • Manassas, Virginia, United States, 20109
        • Recruiting
        • Carient Heart and Vascular
        • Principal Investigator:
          • Vikram Prasanna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
Drug: Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
Other Names:
  • TQJ230
Placebo Comparator: Matching placebo
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Drug: Matching placebo
Matching placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak aortic jet velocity
Time Frame: 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
36 months
Change in aortic valve calcium score
Time Frame: 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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lp(a) levels
Time Frame: 12 months
To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
12 months
Change in fibrocalcific thickening of the aortic valve
Time Frame: 36 months
To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT
36 months
Time from randomization to first occurrence of composite clinical endpoint event
Time Frame: Up to 36 months

To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either:

  1. Unplanned CAVS related hospital admission
  2. Aortic valve intervention
  3. Death related to calcific aortic valve stenosis
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Estimated)

March 12, 2030

Study Completion (Estimated)

March 12, 2030

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTQJ230A12203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with the applicable laws and regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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