Not currently recruiting at UC Irvine

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

a study on Cardiovascular Disease Atherosclerosis Peripheral Artery Disease

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Details

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).

Keywords

Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease, Elevated Lp(a), Cardiovascular disease, Pelacarsen (TQJ230), Cardiovascular Diseases, Atherosclerosis, TQJ230

Eligibility

You can join if…

Open to people ages 18-80

  • 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:

You CAN'T join if...

  • 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

Locations

  • University of Calif Irvine Med Cntr in progress, not accepting new patients
    Irvine California 92660 United States
  • NICRs Research Center in progress, not accepting new patients
    Garden Grove California 92844 United States
  • Long Beach Clinical Trials in progress, not accepting new patients
    Long Beach California 90806 United States
  • Valley Clinical Trials Inc in progress, not accepting new patients
    Covina California 91723 United States
  • Velocity Clinical Trials accepting new patients
    Los Angeles California 90057 United States
  • Discovery Clinical Trials accepting new patients
    Pflugerville Texas 78660-3015 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT06267560
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated