Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

Last Update: Dec 27, 2024

A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

ClinicalTrials.gov Identifier:

NCT06267560

Novartis Reference Number:CTQJ230A12303

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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

Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk. CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).

The study will consist of a screening period of approximately 30 days, followed by a Guideline recommended SoC implementation period of approximately 30 days, if required, and a doubleblind treatment period of 12 months. There will be a post-treatment follow-up period of 16 weeks.

Condition

Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Phase

Phase3

Overall Status

Recruiting

Number of Participants

400

Start Date

Apr 24, 2024

Completion Date

Mar 11, 2027

Gender

All

Age(s)

18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug

Placebo

matching placebo

Drug

TQJ230

TQJ230 80mg QM s.c.

Eligibility Criteria

Inclusion Criteria:

* Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age
* Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
* On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines.
* Established ASCVD disease defined as documented:

* Coronary heart disease (CHD) and/or
* Cerebrovascular disease (CVD) and/or
* Peripheral arterial disease (PAD):

Exclusion Criteria:

* Uncontrolled hypertension
* Heart failure New York Heart Association (NYHA) class IV
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count \<140,000 per mm3
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women

Advanced Clinical Research LLC

Recruiting

Bayamon,00959,Puerto Rico

Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

Study Description

Interventions

Placebo

TQJ230

Eligibility Criteria

Advanced Clinical Research LLC

Vilma Perez

Angel Comulada

Latin Clinical Trial Center Inc

Juana Olivo

Alex Gonzalez Bossolo

Dr Yolanda Figueroa Private Pr

Yolanda Figueroa

VA Caribbean Healthcare System

Jonathan Rolon-Negron

Luis Rodriguez-Ospina

CAIMED Center

Elizabeth A. Barranco

Sara Cancel

Advanced Medical Research Center

Michelle Nunez

Orvil F Martinez Rivera

Research and Cardiovascular Corp

Jose B Vazquez-Tanus

Jovannia Galarza Perez

Monroe Biomedical Research

Awawu Igbinadolor

Anna Drake

James A Haley Veterans Hospital

David Whitaker

Stephanie Gonzalez

Apex Cardiology Research Associates of Jackson

Lani Holman

Mohsin Alhaddad

Discovery Clinical Trials

Brian K MacGillivray

Tracy Fuentes

Metropolitan Cardiovascular Consultants Llc

Sruthi Ramesh

Ayim Akyea-Djamson

Flourish Research

Angelica Perez

Daniel Stokes

Sara Collins

Alfonso Gonzales-Rodriguez

Parkway Medical Center

Trina Gray

James Sullivan

Javara Research

Aslam Khan

Monique Langston

Benjamin Marcum

Ronald M Pucillo

Chelsi Holliday

Aimee Kaczorowsi

Sangeeta Wagner

Gabriela Obeidat

Amara Akujieze

Scott Kahney

Habib Chotani

Amine Segueni

Stacy Jones

Jason Elenberger

Amy Reyna

Kathryn McSpadden

Elite Clinical Research LLC

Honey East

Sister Life Research Inc

Luis Rivera

Idania Cruz

Raul Alonso

Luis Cabrera Haber

Proactive Clinical Research

David Mishkin

Juan Garcia

Maria Coimbra

The Stern Cardiovascular Foundation

Frank Augustus McGrew

Meshun Briscoe