Elevated Lp(a) and Established Atherosclerotic Cardiovascular DiseasePhase 3NCT06267560
Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
A Phase 3 study testing TQJ230 in people with Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 96 sites in 2 countries.
Trial summary
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
- What is being tested?
- TQJ230
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 96 sitesin 2 countries
- Study dates
- 24 Apr 2024to 25 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age
- Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
- On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines.
- Established ASCVD disease defined as documented:
- Coronary heart disease (CHD) and/or
- Cerebrovascular disease (CVD) and/or
- Peripheral arterial disease (PAD):
Who cannot join
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
Trial locations and contacts
96 sites in 2 countries.
96 sites in 2 countries
United States89 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
Alliance Clinical
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
Velocity Clin Research Springdale
Cincinnati, Ohio, 45246
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
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
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
Ctr for Clin Rsch and Innovatn
Houston, Texas, 77008
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 LLC
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
Flourish Research Miami LLC
Miami, Florida, 33135
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
Stanford University Medical Center
Palo Alto, California, 94304
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
Virginia Commonwealth University
Richmond, Virginia, 23298-0111
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
Acclaim Clinical Research
San Diego, California, 92120
University of Washington
Seattle, Washington, 98195
Stern Cardiovascular Foundation Inc
Southaven, Mississippi, 38671
Sugar Lakes Family Practice
Sugar Land, Texas, 77479
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
Puerto Rico7 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
Advance Medical Research Center
San Juan, 00926
About this study
Official title: A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.
Read the detailed description
CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).
- Being tested
- TQJ230, Placebo
- Keywords
- Elevated Lp(a), Cardiovascular disease, Pelacarsen (TQJ230)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQJ230Drug
Also called pelacarsen
TQJ230 80mg QM s.c.
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| TQJ230 | Experimental | TQJ230 80mg QM s.c. Receives: Drug: TQJ230 |
| Placebo | Placebo comparator | Matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in log-transformed Lp(a) concentration from baseline at week 52
The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.
Measured: Baseline, week 52
Secondary outcomes (2)
Incidence proportion of study discontinuations due to TEAEs
Incidence proportion of study discontinuations due to TEAEs will be provided
Measured: Up to 52 weeks
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest will be provided
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start24 Apr 2024
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Lp(a) and Established Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267560
- Sponsor's protocol ID
- CTQJ230A12303
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06267560
- Acronym / sponsor ID
- CTQJ230A12303
- Keywords
- Elevated Lp(a), Cardiovascular disease, Pelacarsen (TQJ230)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.
Detailed description
CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQJ230 | Experimental | Drug: TQJ230TQJ230 80mg QM s.c. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age
- Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
- On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines.
- Established ASCVD disease defined as documented:
Key exclusion criteria (8 listed)
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQJ230Also: pelacarsenTQJ230 80mg QM s.c. | Drug | TQJ230 |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Change in log-transformed Lp(a) concentration from baseline at week 52
Time frame: Baseline, week 52
The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.
2 secondary outcomes
Incidence proportion of study discontinuations due to TEAEs
Time frame: Up to 52 weeks
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: 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
Related trials for Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
Active, not recruitingPhase 3
Pelacarsen Roll-over Extension Program
Atherosclerotic Cardiovascular Disease
Active, not recruitingPhase 3
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Atherosclerotic Cardiovascular Disease (ASCVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
96 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQJ230 in people with Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 96 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in log-transformed Lp(a) concentration from baseline at week 52 (time frame: Baseline, week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.