Last Update: Aug 09, 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:
Novartis Reference Number:CTQJ230A12303
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.

Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
Phase3
Recruiting
400
Apr 24, 2024
Mar 11, 2027
All
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

Cardiovascular Associates Research

Recruiting

Covington,Louisiana,70433,United States

Dale Presser
Melinda Accardo

Pharma Tex Research

Recruiting

Amarillo,Texas,79106,United States

Emily Peterson
David Brabham

Valley Clinical Trials Inc

Recruiting

Covina,California,91723,United States

Mannie Lyons
Fahed Bitar

DBC Research USA

Recruiting

Pembroke Pines,Florida,33029,United States

Alvaro Murcia
Carolyn Zambrano

AB Clinical Trials

Recruiting

Las Vegas,Nevada,89119,United States

Atoya Adams
Anas Alubaidi

Ctr For Clin Rsrch And Innovation Research

Recruiting

Spring,Texas,77389,United States

Adriana Mccray
Amie Sun-Wright

Zenith Clinical Research

Recruiting

Hollywood,Florida,33021,United States

Carmen Rosa
Moises Issa

North Hills Medical Research, Inc .

Recruiting

Bedford,Texas,76021,United States

John D Gabriel
Steven Vasquez

Excel Medical Clinical Trials LLC

Recruiting

Boca Raton,Florida,33434,United States

David Funt
Phillippa Mc Cartney

Clinical Research of South Nevada .

Recruiting

Las Vegas,Nevada,89121,United States

Roger Estevez
Shelly Heredia

Southern Clinical Research Clinic .

Recruiting

Zachary,Louisiana,70791,United States

Ernest Thompson
Tammy Dours

Grady Health System

Recruiting

Atlanta,Georgia,30303,United States

Chadrick M Anderson
Jalal Ghali

Inpatient Research Clinical LLC

Recruiting

Miami Lakes,Florida,33014,United States

Alexis Gutierrez
Illyanis Marino

Virginia Heart

Recruiting

Falls Church,Virginia,22042,United States

Cynthia E Alvarez
Tariq Haddad

C and A Clinical Trials

Recruiting

Cape Coral,Florida,33990,United States

Arturo Alvarez
Juan Antonio Carmona Herrera

SW Family Medicine Associates

Recruiting

Dallas,Texas,75235,United States

Chrisette Dharma
Kehinde Ogunremi

Cardiology and Medicine Clinic, PA

Recruiting

Little Rock,Arkansas,72204,United States

Joe L Hargrove

Apex Cardiology Research Associates of Jackson

Recruiting

Jackson,Tennessee,38301,United States

Lani Holman
Mohsin Alhaddad

Anderson Medical Research

Recruiting

Fort Washington,Maryland,20744,United States

Felton Anderson

Cambridge Medical Trials .

Recruiting

Alexandria,Louisiana,71301,United States

Mitzi Carmouche
Naseem A Jaffrani

Eminat LLC

Recruiting

Miramar,Florida,33027,United States

Sandra Negrete
Yaneth Trujillo

Dominion Medical Associates

Recruiting

Richmond,Virginia,23219,United States

Claretha Nelson
Richard A Jackson

Clinical Trials of Texas .

Recruiting

San Antonio,Texas,78229,United States

Douglas Denham
Sandra Howard

Proactive Clinical Research

Recruiting

Fort Lauderdale,Florida,33308,United States

Beatriz Ramirez
David Mishkin

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals