Last Update: Aug 07, 2026 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: [NCT06813911](https://clinicaltrials.gov/ct2/show/NCT06813911) Novartis Reference Number:CTQJ230A12304 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 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. Condition Atherosclerotic Cardiovascular Disease (ASCVD) Phase Phase3 Overall Status Recruiting Number of Participants340 Start Date Apr 30, 2025 Completion Date Feb 29, 2028 Gender All Age(s) 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. China #### Novartis Investigative Site Recruiting Shanghai,200025,China #### Novartis Investigative Site Recruiting Jining,Shandong,272000,China #### Novartis Investigative Site Recruiting Xian,Shanxi,710061,China #### Novartis Investigative Site Recruiting Beijing,100730,China France #### Novartis Investigative Site Recruiting Pessac,33604,France #### Novartis Investigative Site Recruiting Béziers,34525,France #### Novartis Investigative Site Recruiting Cholet,49325,France #### Novartis Investigative Site Recruiting Lille,59037,France #### Novartis Investigative Site Recruiting Montpellier,34295,France #### Novartis Investigative Site Recruiting Paris,75013,France #### Novartis Investigative Site Recruiting Poitiers,86021,France #### Novartis Investigative Site Recruiting Toulouse,31054,France Germany #### Novartis Investigative Site Recruiting Chemnitz,Saxony,09113,Germany #### Novartis Investigative Site Recruiting Leipzig,Saxony,04103,Germany #### Novartis Investigative Site Recruiting Berlin,10789,Germany #### Novartis Investigative Site Recruiting Potsdam,Brandenburg,14473,Germany #### Novartis Investigative Site Recruiting Stuttgart,Baden-Wurttemberg,70376,Germany #### Novartis Investigative Site Recruiting Bielefeld,33604,Germany #### Novartis Investigative Site Recruiting Gelnhausen,63571,Germany #### Novartis Investigative Site Recruiting Mannheim,68165,Germany #### Novartis Investigative Site Recruiting Münster,48145,Germany #### Novartis Investigative Site Recruiting Singen,78224,Germany Hong Kong #### Novartis Investigative Site Recruiting Hong Kong,999077,Hong Kong Italy #### Novartis Investigative Site Recruiting Rozzano,MI,20089,Italy #### Novartis Investigative Site Recruiting Milan,MI,20138,Italy #### Novartis Investigative Site Recruiting Grosseto,GR,58100,Italy #### Novartis Investigative Site Recruiting Caserta,CE,81100,Italy #### Novartis Investigative Site Recruiting Ancona,AN,60020,Italy #### Novartis Investigative Site Recruiting Salerno,SA,84131,Italy #### Novartis Investigative Site Recruiting Pordenone,PN,33170,Italy #### Novartis Investigative Site Recruiting Legnago,VR,37045,Italy #### Novartis Investigative Site Recruiting Perugia,PG,06129,Italy Netherlands #### Novartis Investigative Site Recruiting The Hague,South Holland,2545 aa,Netherlands #### Novartis Investigative Site Recruiting Enschede,7512kz,Netherlands Spain #### Novartis Investigative Site Recruiting Córdoba,14004,Spain #### Novartis Investigative Site Recruiting Valencia,46010,Spain #### Novartis Investigative Site Recruiting Valencia,46014,Spain #### Novartis Investigative Site Recruiting Salamanca,37007,Spain #### Novartis Investigative Site Recruiting Las Palmas GC,35010,Spain #### Novartis Investigative Site Recruiting Huelva,21080,Spain #### Novartis Investigative Site Recruiting Barcelona,08023,Spain #### Novartis Investigative Site Recruiting A Coruña,15006,Spain #### Novartis Investigative Site Recruiting Castilleja de la Cuesta,Sevilla,41950,Spain #### Novartis Investigative Site Recruiting Pamplona,Navarre,31008,Spain #### Novartis Investigative Site Recruiting Santiago Compostela,A Coruna,15706,Spain Taiwan #### Novartis Investigative Site Recruiting Tainan,704,Taiwan #### Novartis Investigative Site Recruiting Kaohsiung City,80756,Taiwan #### Novartis Investigative Site Recruiting Changhua,50006,Taiwan United Kingdom #### Novartis Investigative Site Recruiting London,W12 0hs,United Kingdom #### Novartis Investigative Site Recruiting Manchester,M13 9wl,United Kingdom #### Novartis Investigative Site Recruiting Tyne and Wear,Ne29 8nh,United Kingdom #### Novartis Investigative Site Recruiting London,Ec1m 6bq,United Kingdom #### Novartis Investigative Site Recruiting Chichester,West Sussex,Po19 6se,United Kingdom United States #### Virginia Heart Recruiting Falls Church,Virginia,22042,United States ###### Tariq Haddad ###### Deanna Overbeck Phone: [+1 703 766 5920]() Email: #### Baptist Health South Recruiting Miami,Florida,33173,United States ###### Adedapo Iluyomade ###### Ruben Dominguez Phone: [+1 786 595 8078]() Email: #### University Of South Florida Recruiting Tampa,Florida,33612,United States ###### Amanda McNamara Email: ###### Shone Almeida #### Novartis Investigative Site Recruiting Tullahoma,Tennessee,37388,United States ###### Dinesh Gupta ###### Kayla Nee Phone: [+1 931 393 7831]() Email: #### Jacksonville Center for Clinical Recruiting Jacksonville,Florida,32216,United States ###### Theresa Hanburry Phone: [+1 904 730 0101]() Email: ###### Michael J Koren #### Anderson Medical Research Recruiting Ft. Washington,Maryland,20744,United States ###### Felton Anderson ###### Ann-Marie Cobb Email: #### Overlook Medical Center Recruiting Summit,New Jersey,07901,United States ###### Robert Fishberg ###### Betty Merveil-Ceneus Email: #### Ocala Cardiovascular Research Recruiting Ocala,Florida,34471,United States ###### Lan Luo ###### Arleana Brown Email: #### FC Site Partners Miami Recruiting Winter Park,Florida,32789,United States ###### Monica Aggarwal ###### Claisha Pruitt Email: #### Flourish Research Bowie Recruiting Bowie,Maryland,20715,United States ###### Sara Collins ###### Weemon Reed Email: #### Northwest Houston Clinical Research PLLC Recruiting Tomball,Texas,77375,United States ###### Shamaila Aslam ###### Dawn Burns Phone: [+1 281 351 4911]() Email: #### Omega Clinical Research Recruiting Metairie,Louisiana,70006,United States ###### Tuan-Huy Tran ###### Tina Messina Phone: [+1 504 914 8726]() Email: #### PharmaTex Research LLC Recruiting Amarillo,Texas,79106,United States ###### David Brabham ###### Salma Villarreal Phone: [+1 806 355 2581]() Email: #### Intermountain Medical Center Recruiting Murray,Utah,84107,United States ###### Tyler Winslow Phone: [+1 801 507 4777]() Email: ###### Jeffrey Anderson #### Wake Forest University Baptist Medical Center Recruiting Winston-Salem,North Carolina,27157,United States ###### Michael Shapiro ###### Keishia Rodriguez Email: #### Advocate Lutheran General Childrens Hospital Recruiting Park Ridge,Illinois,60068,United States ###### Stacey Pahlke Email: ###### Adib Chaus #### Kelsey Seybold Research Foundation Recruiting Houston,Texas,77030,United States ###### Julian Edmonson Phone: [+1 713 791 6989]() Email: ###### Fisayomi Shobayo #### American Health Network Research Dept Recruiting Muncie,Indiana,47304,United States ###### Stephanie Stewart Phone: [+1 765 213 2876]() Email: [stephanie\_stewart@ahni.com](mailto:stephanie_stewart@ahni.com) ###### Jonathan Condit ###### Gorgi Leigh Avery Email: [gorgi\_avery@ahni.com](mailto:gorgi_avery@ahni.com) ###### Andrew Daluga #### Peace River Cardiovascular Center Recruiting Port Charlotte,Florida,33952,United States ###### Karen Mullinax Phone: [+1 941 629 5356]() Email: ###### David Allan Hotchkiss #### SEC Clinical Research Recruiting Pensacola,Florida,32503,United States ###### Tatum Ramsey Phone: [+1 850 696 7148]() Email: ###### Robert I Garver ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: