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

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.

Conditions

Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
Intervention / Treatment

-

Contacts and Locations

Little Rock

Cardiology and Medicine Clinic, PA, Little Rock, Arkansas, United States, 72204

Covina

Valley Clinical Trials Inc, Covina, California, United States, 91723

Boca Raton

Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States, 33434

Cape Coral

C and A Clinical Trials, Cape Coral, Florida, United States, 33990

Fort Lauderdale

Proactive Clinical Research, Fort Lauderdale, Florida, United States, 33308

Hollywood

Zenith Clinical Research, Hollywood, Florida, United States, 33021

Miami Lakes

Inpatient Research Clinical LLC, Miami Lakes, Florida, United States, 33014

Miramar

Eminat LLC, Miramar, Florida, United States, 33027

Pembroke Pines

DBC Research USA, Pembroke Pines, Florida, United States, 33029

Atlanta

Grady Health System, Atlanta, Georgia, United States, 30303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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):
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2027-03-11