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.
Interventions
Inclisiran
Pelacarsen
Placebo
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.
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Shanghai,200025,China
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Jining,Shandong,272000,China
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Xian,Shanxi,710061,China
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Beijing,100730,China
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Pessac,33604,France
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Béziers,34525,France
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Cholet,49325,France
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Lille,59037,France
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Montpellier,34295,France
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Paris,75013,France
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Poitiers,86021,France
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Toulouse,31054,France
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Chemnitz,Saxony,09113,Germany
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Leipzig,Saxony,04103,Germany
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Berlin,10789,Germany
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Potsdam,Brandenburg,14473,Germany
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Stuttgart,Baden-Wurttemberg,70376,Germany
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Bielefeld,33604,Germany
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Gelnhausen,63571,Germany
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Mannheim,68165,Germany
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Münster,48145,Germany
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Singen,78224,Germany
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Hong Kong,999077,Hong Kong
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Rozzano,MI,20089,Italy
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Milan,MI,20138,Italy
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Grosseto,GR,58100,Italy
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Caserta,CE,81100,Italy
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Ancona,AN,60020,Italy
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Salerno,SA,84131,Italy
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Pordenone,PN,33170,Italy
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Legnago,VR,37045,Italy
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Perugia,PG,06129,Italy
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The Hague,South Holland,2545 aa,Netherlands
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Enschede,7512kz,Netherlands
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Córdoba,14004,Spain
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Valencia,46010,Spain
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Valencia,46014,Spain
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Salamanca,37007,Spain
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Las Palmas GC,35010,Spain
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Huelva,21080,Spain
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Barcelona,08023,Spain
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A Coruña,15006,Spain
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Castilleja de la Cuesta,Sevilla,41950,Spain
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Pamplona,Navarre,31008,Spain
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Santiago Compostela,A Coruna,15706,Spain
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Tainan,704,Taiwan
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Kaohsiung City,80756,Taiwan
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Changhua,50006,Taiwan
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London,W12 0hs,United Kingdom
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Manchester,M13 9wl,United Kingdom
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Tyne and Wear,Ne29 8nh,United Kingdom
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London,Ec1m 6bq,United Kingdom
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Chichester,West Sussex,Po19 6se,United Kingdom
Virginia Heart
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Falls Church,Virginia,22042,United States
Tariq Haddad
Baptist Health South
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Miami,Florida,33173,United States
Adedapo Iluyomade
University Of South Florida
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Tampa,Florida,33612,United States
Amanda McNamara
Shone Almeida
Novartis Investigative Site
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Tullahoma,Tennessee,37388,United States
Dinesh Gupta
Jacksonville Center for Clinical
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Jacksonville,Florida,32216,United States
Michael J Koren
Anderson Medical Research
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Ft. Washington,Maryland,20744,United States
Felton Anderson
Ann-Marie Cobb
Overlook Medical Center
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Summit,New Jersey,07901,United States
Robert Fishberg
Betty Merveil-Ceneus
Ocala Cardiovascular Research
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Ocala,Florida,34471,United States
Lan Luo
Arleana Brown
FC Site Partners Miami
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Winter Park,Florida,32789,United States
Monica Aggarwal
Claisha Pruitt
Flourish Research Bowie
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Bowie,Maryland,20715,United States
Sara Collins
Weemon Reed
Northwest Houston Clinical Research PLLC
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Tomball,Texas,77375,United States
Shamaila Aslam
Omega Clinical Research
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Metairie,Louisiana,70006,United States
Tuan-Huy Tran
PharmaTex Research LLC
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Amarillo,Texas,79106,United States
David Brabham
Intermountain Medical Center
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Murray,Utah,84107,United States
Jeffrey Anderson
Wake Forest University Baptist Medical Center
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Winston-Salem,North Carolina,27157,United States
Michael Shapiro
Keishia Rodriguez
Advocate Lutheran General Childrens Hospital
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Park Ridge,Illinois,60068,United States
Stacey Pahlke
Adib Chaus
Kelsey Seybold Research Foundation
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Houston,Texas,77030,United States
Fisayomi Shobayo
American Health Network Research Dept
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Muncie,Indiana,47304,United States
Jonathan Condit
Gorgi Leigh Avery
Andrew Daluga
Peace River Cardiovascular Center
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Port Charlotte,Florida,33952,United States
David Allan Hotchkiss
SEC Clinical Research
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Pensacola,Florida,32503,United States
Robert I Garver
Worldwide Contacts
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