Last Update: Sep 19, 2025
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CTQJ230A12304
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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). This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Atherosclerotic Cardiovascular Disease (ASCVD)
Phase3
Recruiting
340
Apr 30, 2025
Dec 01, 2027
All
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug

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.
Drug

Pelacarsen

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

Placebo

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

Eligibility Criteria

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.

Novartis Investigative Site

Recruiting

Xian,Shanxi,710061,China

Novartis Investigative Site

Recruiting

Beijing,100730,China

Novartis Investigative Site

Recruiting

Pokfulam,999077,Hong Kong

Latin Clinical Trial Center Inc

Recruiting

San Juan,00909,Puerto Rico

Liz Pagan
Alex Gonzalez Bossolo

Novartis Investigative Site

Recruiting

London,W12 0hs,United Kingdom

Anderson Medical Research

Recruiting

Fort Washington,Maryland,20744,United States

Felton Anderson
Lian Glorioso
Lian Glorioso
Felton Anderson

Virginia Heart

Recruiting

Falls Church,Virginia,22042,United States

Tariq Haddad
Noelia Garcia
Kathleen Culclasure

Overlook Medical Center

Recruiting

Summit,New Jersey,07901,United States

Robert Fishberg
Betty Merveil-Ceneus
Andrea Mojica-Brid

Cardiovascular Associates Research

Recruiting

Covington,Louisiana,70433,United States

Elnie Williams
Dale Presser
Celeste Casale

National Heart Institute

Recruiting

Beverly Hills,California,90211,United States

Norman Lepor
Maria Flores

Clinical Research Inst of Arizona

Recruiting

Sun City West,Arizona,85375,United States

Ashley Pace
Jalal Abbas

Jacksonville Center for Clinical

Recruiting

Jacksonville,Florida,32216,United States

Brenda Anderson
Michael J Koren

University of Miami Hospital

Recruiting

Miami,Florida,33136,United States

Andrew Bromley
Daniella Estevez

Aa Mrc Llc

Recruiting

Flint,Michigan,48504,United States

Ahmed Arif
Rania Takriti

AB Clinical Trials

Recruiting

Las Vegas,Nevada,89119,United States

Atoya Adams
Natalie Evans

PharmaTex Research LLC

Recruiting

Amarillo,Texas,791064165,United States

Alexandra Muniz Sims
David Brabham

Excel Medical Clinical Trials LLC

Recruiting

Boca Raton,Florida,33434,United States

Mariana Sanchez Villa
Rimsky Denis
Krystel Gonzalez

Inpatient Research Clinical LLC

Recruiting

Miami Lakes,Florida,33014,United States

Alexis Gutierrez
Arazay Perez
Arazay Perez
Ilianis Marino
Jesus Cid
Jose Contreras

Eminat LLC

Recruiting

Miramar,Florida,33027,United States

Diana Hernandez
Leonardo Salazar
Yaneth Trujillo

Omega Clinical Research

Recruiting

Metairie,Louisiana,70006,United States

Rosina Ducote
Tuan-Huy Tran

Henry Ford Hospital

Recruiting

Detroit,Michigan,48202,United States

Khaled Abdul-Nour
Meghan Mc Carthy

Cardiology Group

Recruiting

Tullahoma,Tennessee,37388,United States

Dinesh Gupta
Kayla Nee

Northwest Houston Clinical Research PLLC

Recruiting

Tomball,Texas,77375,United States

Dawn Burns
Reeja Mehboob
Shamaila Aslam

FC Site Partners Miami

Recruiting

Winter Park,Florida,32789,United States

Alfonso Gonzalez-Rodriguez
Juan Carlos Olaya
Laura Correa

PharmaTex Research LLC

Recruiting

Amarillo,Texas,79106 4165,United States

Alexandra Muniz Sims
David Brabham

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals