AzTrials
AzTrials

Atherosclerotic Cardiovascular DiseasePhase 3NCT06875973

Pelacarsen Roll-over Extension Program

A Phase 3 study testing Pelacarsen (TQJ230) in people with Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 89 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Atherosclerotic Cardiovascular Disease
What is being tested?
Pelacarsen (TQJ230)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
599 participants
Where
89 sitesin 2 countries
Study dates
19 May 2025to 8 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
  • Participants who have completed the parent study and received the assigned study treatment at the time of its completion

Who cannot join

  • Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
  • Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
  • Participants who are receiving another investigational drug or device before the open-label treatment period
  • Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

89 sites in 2 countries.

89 sites in 2 countries

United States83 sites

  • Javara Research

    Alexandria, Virginia, 22311

  • Plano Primary Care Clinic

    Allen, Texas, 75002-3688

  • Pharma Tex Research

    Amarillo, Texas, 79106

  • Morehouse School Of Medicine

    Atlanta, Georgia, 30310

  • Sinai Ct for Throm Res and Drug Dev

    Baltimore, Maryland, 21209

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland, 21229

  • Johns Hopkins Univ School of Med

    Baltimore, Maryland, 21287

  • North Hills Medical Research Inc

    Bedford, Texas, 76021

  • Metropolitan Cardiovascular Consultants Llc

    Beltsville, Maryland, 20705

  • National Heart Institute

    Beverly Hills, California, 90211

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida, 33434

  • Hope Clinical Research

    Canoga Park, California, 91303

  • C and A Clinical Trials

    Cape Coral, Florida, 33990

  • Synexus Clinical Research US Inc

    Chicago, Illinois, 60602

  • Chicago Clinical Research Inst

    Chicago, Illinois, 60607

  • Johns Hopkins University

    Columbia, Maryland, 21044

  • Valley Clinical Trials Inc

    Covina, California, 91723

  • Cardiovascular Associates Research

    Covington, Louisiana, 70433

  • SW Family Medicine Associates

    Dallas, Texas, 75235

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Care Access Research

    Easton, Pennsylvania, 18045

  • David Turbay MD PLLC

    El Paso, Texas, 79905

  • Virginia Heart

    Falls Church, Virginia, 22042

  • Aa Mrc Mhs

    Flint, Michigan, 48503

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Proactive Clinical Research

    Fort Lauderdale, Florida, 33308

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744

  • NICRs Research Center

    Garden Grove, California, 92844

  • Las Vegas Endocrinology

    Henderson, Nevada, 89074

  • National Research Institute

    Hialeah, Florida, 33013

  • Sister Life Research Inc

    Hialeah, Florida, 33013

  • Zenith Clinical Research

    Hollywood, Florida, 33021

  • Heart Care Associates P C

    Hopewell, Virginia, 23860

  • Angiocardiac Care of Texas PA

    Houston, Texas, 77025

  • Dallas Heart and Vascular Consultants PA

    Houston, Texas, 77084

  • University of Calif Irvine Med Cntr

    Irvine, California, 92660

  • Elite Clinical Research

    Jackson, Mississippi, 39202

  • Apex Cardiology Research Associates of Jackson

    Jackson, Tennessee, 38301

  • Capitol Cardiology Associates

    Lanham, Maryland, 20706

  • AB Clinical Trials

    Las Vegas, Nevada, 89119

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Epic Clinical Research

    Lewisville, Texas, 75057

  • NexGen Research

    Lima, Ohio, 45801

  • TCV Clinical Studies

    Linwood, Pennsylvania, 19061

  • Cardiology and Medicine Clinic PA

    Little Rock, Arkansas, 72204

  • Long Beach Clinical Trials

    Long Beach, California, 90806

  • Angel City Research Inc

    Los Angeles, California, 90026

  • The Heart Institute of East Texas

    Lufkin, Texas, 75904

  • Omega Clinical Research

    Metairie, Louisiana, 70006

  • Columbus Clinical Services LLC

    Miami, Florida, 33125

  • Finlay Medical Research

    Miami, Florida, 33126

  • Infinite Clinical Research

    Miami, Florida, 33133

  • International Research Associates LLC

    Miami, Florida, 33156

  • Baptist Health South

    Miami, Florida, 33173

  • A&A Research Group Inc

    Miami, Florida, 33186

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014

  • FXM Clin Res Miramar LLC

    Miramar, Florida, 33027

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • California Medical Research Associates Inc

    Northridge, California, 91324

  • CV Ins of the South

    Opelousas, Louisiana, 70570

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • CTMD Research

    Palm Springs, Florida, 33406

  • DBC Research USA

    Pembroke Pines, Florida, 33029

  • Discovery Clinical Trials

    Pflugerville, Texas, 78660-3015

  • Alliance Medical Ministry

    Raleigh, North Carolina, 27610

  • Dominion Medical Associates

    Richmond, Virginia, 23219

  • Vcu Health

    Richmond, Virginia, 23298

  • Jamaica Hospital Medical Center

    Richmond Hill, New York, 11418

  • University of Texas Health Science Ctr

    San Antonio, Texas, 78229-3900

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • University of Washington

    Seattle, Washington, 98195

  • Stern Cardiovascular Foundation Inc

    Southaven, Mississippi, 38671

  • Stanford Health Care

    Stanford, California, 94305

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • New Tampa Health

    Tampa, Florida, 33603

  • James A Haley Veterans Hospital

    Tampa, Florida, 33612

  • Atlanta Heart Specialists LLC

    Tucker, Georgia, 30084

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida, 33449

  • Monroe Research Llc

    West Monroe, Louisiana, 71291

  • Flourish Research

    Winter Park, Florida, 32789

  • Southern Clin Research Clinic

    Zachary, Louisiana, 70791

Other trials in United States

Puerto Rico6 sites

  • Advanced Clinical Research LLC

    Bayamón, 00959

  • Dr Yolanda Figueroa Private Pr

    Humacao, 00791

  • CAIMED Center

    Ponce, 00716

  • Research and Cardiovascular Corp

    Ponce, 00717-1322

  • Latin Clinical Trial Center Inc

    San Juan, 00909

  • VA Caribbean Healthcare System

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.

Read the detailed description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Being tested
Pelacarsen (TQJ230)
Keywords
TQJ230, Lp(a), ASCVD
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelacarsen (TQJ230)Drug

    Also called TQJ230

    pelacarsen 80mg s.c. monthly

Study groups in NCT06875973
Study groupRoleWhat they receive
Pelacarsen (TQJ230)Experimentalopen-label pelacarsen 80mg
Receives: Drug: Pelacarsen (TQJ230)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse events (AEs) or serious adverse events (SAEs)

    Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study

    Measured: Up to 48 months

Secondary outcomes (2)

  1. Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study

    Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels

    Measured: Baseline of the core study, Month 3, 12, 24, 36, 48

  2. Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study

    Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels

    Measured: Baseline of the REP study, Month 3, 12, 24, 36, 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start19 May 2025
  3. Primary completion8 Dec 2030 (estimated)
  4. Study completion8 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Rollover extension program (REP)
Masking
None (open label)
Enrolment
599 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06875973
Sponsor's protocol ID
CTQJ230A12305B
Status last verified
Oct 2026
First submitted
12 Mar 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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 applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pelacarsen (TQJ230) in people with Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 89 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse events (AEs) or serious adverse events (SAEs) (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06875973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in