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NCT06813911PHASE3Recruiting

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Novartis Pharmaceuticals

Start Date

4/30/2025

Completion Date

2/29/2028

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).

Detailed Description

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

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

Pelacarsen

DRUG

Placebo

DRUG

Inclisiran

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Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)

Locations

Parkway Medical Center

Birmingham, Alabama 35215

United States

Clinical Research Inst of Arizona

Sun City West, Arizona 85375

United States

National Heart Institute

Beverly Hills, California 90211

United States

Interv Cardiology Med Grp

West Hills, California 91307

United States

Excel Medical Clinical Trials LLC

Boca Raton, Florida 33434

United States

Jacksonville Center for Clinical

Jacksonville, Florida 32216

United States

K2 Medical Research LLC

Maitland, Florida 32751

United States

University of Miami Hospital

Miami, Florida 33136

United States

Baptist Health South

Miami, Florida 33173

United States

Inpatient Research Clinical LLC

Miami Lakes, Florida 33014

United States

FXM Clin Res Miramar LLC

Miramar, Florida 33027

United States

Ocala Cardiovascular Research

Ocala, Florida 34471

United States

SEC Clinical Research

Pensacola, Florida 32503

United States

Peace River Cardiovascular Center

Port Charlotte, Florida 33952

United States

University Of South Florida

Tampa, Florida 33612

United States

FC Site Partners Miami

Winter Park, Florida 32789

United States

Advocate Lutheran General Childrens Hospital

Park Ridge, Illinois 60068

United States

American Health Network Research Dept

Muncie, Indiana 47304

United States

American Health Network Research Dept

Muncie, Indiana 47304

United States

Cardiovascular Associates Research

Covington, Louisiana 70433

United States

Omega Clinical Research

Metairie, Louisiana 70006

United States

Flourish Research Bowie

Bowie, Maryland 20715

United States

Anderson Medical Research

Ft. Washington, Maryland 20744

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Aa Mrc Llc

Flint, Michigan 48504

United States

MyMichigan Medical Center Midland

Midland, Michigan 48670

United States

AB Clinical Trials

Las Vegas, Nevada 89119

United States

Overlook Medical Center

Summit, New Jersey 07901

United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

The Corvallis Clinic P C

Corvallis, Oregon 97330

United States

Novartis Investigative Site

Tullahoma, Tennessee 37388

United States

PharmaTex Research LLC

Amarillo, Texas 79106

United States

Kelsey Seybold Research Foundation

Houston, Texas 77030

United States

Northwest Houston Clinical Research PLLC

Tomball, Texas 77375

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Virginia Heart

Falls Church, Virginia 22042

United States

Novartis Investigative Site

Yinchuan, Ningxia 750004

China

Novartis Investigative Site

Jining, Shandong 272000

China

Novartis Investigative Site

Xian, Shanxi 710061

China

Novartis Investigative Site

Beijing, 100730

China

Novartis Investigative Site

Shanghai, 200025

China

Novartis Investigative Site

Béziers, 34525

France

Novartis Investigative Site

Cholet, 49325

France

Novartis Investigative Site

Grenoble, 38043

France

Novartis Investigative Site

Lille, 59037

France

Novartis Investigative Site

Montpellier, 34295

France

Novartis Investigative Site

Paris, 75013

France

Novartis Investigative Site

Pessac, 33604

France

Novartis Investigative Site

Poitiers, 86021

France

Novartis Investigative Site

Toulouse, 31054

France

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg 70376

Germany

Novartis Investigative Site

Potsdam, Brandenburg 14473

Germany

Novartis Investigative Site

Chemnitz, Saxony 09113

Germany

Novartis Investigative Site

Leipzig, Saxony 04103

Germany

Novartis Investigative Site

Berlin, 10789

Germany

Novartis Investigative Site

Bielefeld, 33604

Germany

Novartis Investigative Site

Gelnhausen, 63571

Germany

Novartis Investigative Site

Mannheim, 68165

Germany

Novartis Investigative Site

Münster, 48145

Germany

Novartis Investigative Site

Singen, 78224

Germany

Novartis Investigative Site

Hong Kong, Hong Kong 999077

Hong Kong

Novartis Investigative Site

Hong Kong, 999077

Hong Kong

Novartis Investigative Site

Ancona, AN 60020

Italy

Novartis Investigative Site

Caserta, CE 81100

Italy

Novartis Investigative Site

Grosseto, GR 58100

Italy

Novartis Investigative Site

Milan, MI 20138

Italy

Novartis Investigative Site

Rozzano, MI 20089

Italy

Novartis Investigative Site

Perugia, PG 06129

Italy

Novartis Investigative Site

Pordenone, PN 33170

Italy

Novartis Investigative Site

Salerno, SA 84131

Italy

Novartis Investigative Site

Legnago, VR 37045

Italy

Novartis Investigative Site

The Hague, South Holland 2545 AA

Netherlands

Novartis Investigative Site

Enschede, 7512KZ

Netherlands

Latin Clinical Trial Center Inc

San Juan, 00909

Puerto Rico

Novartis Investigative Site

Santiago Compostela, A Coruna 15706

Spain

Novartis Investigative Site

Pamplona, Navarre 31008

Spain

Novartis Investigative Site

Castilleja de la Cuesta, Sevilla 41950

Spain

Novartis Investigative Site

A Coruña, 15006

Spain

Novartis Investigative Site

Barcelona, 08023

Spain

Novartis Investigative Site

Córdoba, 14004

Spain

Novartis Investigative Site

Huelva, 21080

Spain

Novartis Investigative Site

Las Palmas GC, 35010

Spain

Novartis Investigative Site

Salamanca, 37007

Spain

Novartis Investigative Site

Valencia, 46010

Spain

Novartis Investigative Site

Valencia, 46014

Spain

Novartis Investigative Site

Changhua, 50006

Taiwan

Novartis Investigative Site

Kaohsiung City, 80756

Taiwan

Novartis Investigative Site

Tainan, 704

Taiwan

Novartis Investigative Site

Taipei, 10002

Taiwan

Novartis Investigative Site

Taipei, 11217

Taiwan

Novartis Investigative Site

Chichester, West Sussex PO19 6SE

United Kingdom

Novartis Investigative Site

London, EC1M 6BQ

United Kingdom

Novartis Investigative Site

London, W12 0HS

United Kingdom

Novartis Investigative Site

Manchester, M13 9WL

United Kingdom

Novartis Investigative Site

Tyne and Wear, NE29 8NH

United Kingdom