Recruiting
Phase 3

Pelacarsen

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06813911

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pelacarsen

Placebo

Inclisiran

Study Details

Brief summary:

The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)

Study ID

NCT06813911

Start date

Apr 30, 2025

Status verified date

Aug, 2026

Completion date

Feb 29, 2028

Anticipated

Primary completion date

Feb 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion criteria:

  • Male and female participants 18 to ≤80 years of age at Screening visit
  • Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
  • On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
  • Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
  • On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
  • Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
  • Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit

Key Exclusion Criteria:

  • Prior treatment with inclisiran
  • Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
  • Uncontrolled hypertension at Randomization/Baseline visit
  • Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
  • Triglycerides ≥400 mg/dL at Screening visit
  • History of malignancy of any organ system within the past 5 years
  • Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
  • Central laboratory reported platelet count <140,000 per mm3
  • Active liver disease or hepatic dysfunction at Screening visit
  • Significant kidney disease at Screening visit
  • Pregnant or nursing women at Screening visit
  • Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit

  • Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pelacarsen

Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.

placebo comparator: Placebo

Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period.

Interventions

Pelacarsen

Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.

Placebo

Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.

Inclisiran

All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.

Primary outcome measure

  • Change in log transformed lipoprotein A (Lp(a)) concentration [ Time Frame: Baseline, 6 Months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Jacksonville Center for Clinical

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Theresa Hanburry

+1 904 730 0101thanburry@encoredocs.com

Principal Investigator:

Michael J Koren

Baptist Health South

Recruiting

Miami, Florida, United States, 33173

Contacts

Ruben Dominguez

+1 786 595 8078Ruben.Dominguez@baptisthealth.net

Principal Investigator:

Adedapo Iluyomade

Ocala Cardiovascular Research

Recruiting

Ocala, Florida, United States, 34471

Contacts

Arleana Brown

arleana.brown@morganmmc.com

Principal Investigator:

Lan Luo

SEC Clinical Research

Recruiting

Pensacola, Florida, United States, 32503

Contacts

Tatum Ramsey

+1 850 696 7148tramsey@secclinicalresearch.com

Principal Investigator:

Robert I Garver

Peace River Cardiovascular Center

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

Karen Mullinax

+1 941 629 5356karen@prcvcfl.com

Principal Investigator:

David Allan Hotchkiss

University Of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Amanda McNamara

alett1@usf.edu

Principal Investigator:

Shone Almeida

FC Site Partners Miami

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Claisha Pruitt

cpruitt@flourishresearch.com

Principal Investigator:

Monica Aggarwal

Advocate Lutheran General Childrens Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Stacey Pahlke

Stacey.Pahlke@aah.org

Principal Investigator:

Adib Chaus

American Health Network Research Dept

Recruiting

Muncie, Indiana, United States, 47304

Contacts

Stephanie Stewart

+1 765 213 2876stephanie_stewart@ahni.com

Principal Investigator:

Jonathan Condit

American Health Network Research Dept

Recruiting

Muncie, Indiana, United States, 47304

Contacts

Gorgi Leigh Avery

gorgi_avery@ahni.com

Principal Investigator:

Andrew Daluga

Omega Clinical Research

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Tina Messina

+1 504 914 8726tmessinarn@gmail.com

Principal Investigator:

Tuan-Huy Tran

Flourish Research Bowie

Recruiting

Bowie, Maryland, United States, 20715

Contacts

Weemon Reed

wreed@flourishresearch.com

Principal Investigator:

Sara Collins

Anderson Medical Research

Recruiting

Ft. Washington, Maryland, United States, 20744

Contacts

Ann-Marie Cobb

andersonmedicalresearch@gmail.com

Principal Investigator:

Felton Anderson

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Betty Merveil-Ceneus

betty.merveil-ceneus@atlantichealth.org

Principal Investigator:

Robert Fishberg

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Keishia Rodriguez

keishia.rodriguez@advocatehealth.org

Principal Investigator:

Michael Shapiro

Novartis Investigative Site

Recruiting

Tullahoma, Tennessee, United States, 37388

Contacts

Kayla Nee

+1 931 393 7831kntcct2@gmail.com

Principal Investigator:

Dinesh Gupta

PharmaTex Research LLC

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Salma Villarreal

+1 806 355 2581sestradaptx@gmail.com

Principal Investigator:

David Brabham

Kelsey Seybold Research Foundation

Recruiting

Houston, Texas, United States, 77030

Contacts

Julian Edmonson

+1 713 791 6989julian.edmonson@kelseyresearch.com

Principal Investigator:

Fisayomi Shobayo

Northwest Houston Clinical Research PLLC

Recruiting

Tomball, Texas, United States, 77375

Contacts

Dawn Burns

+1 281 351 4911dburns@houstonheartcenter.com

Principal Investigator:

Shamaila Aslam

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Tyler Winslow

+1 801 507 4777tyler.winslow@imail.org

Principal Investigator:

Jeffrey Anderson

Virginia Heart

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Deanna Overbeck

+1 703 766 5920Doverbeck@VirginiaHeart.com

Principal Investigator:

Tariq Haddad

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Lipoprotein(a)
  • cardiovascular disease
  • ASCVD
  • pelacarsen (TQJ230)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-07.