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Lowering Lp(a) levels in Black and Hispanic patients with heart disease

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

Phase 3 Interventional Novartis · NCT06267560

This study is testing if a new treatment can lower a specific cholesterol level in Black and Hispanic patients with heart disease to see if it helps improve their health.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorNovartis Industry-sponsored
Locations113 sites (Birmingham, Alabama and 112 other locations)
Trial IDNCT06267560 on ClinicalTrials.gov

What this trial studies

This Phase IIIb clinical trial evaluates the efficacy, safety, and tolerability of pelacarsen (TQJ230) in reducing elevated Lp(a) levels in US Black/African American and Hispanic participants who have established atherosclerotic cardiovascular disease (ASCVD). Participants will be randomly assigned to receive either the treatment or a placebo, and the study will measure the effectiveness of the drug in lowering Lp(a) levels compared to the placebo. The trial aims to include individuals who are already on standard care for cardiovascular risk factors. The study is conducted across multiple centers in the United States.

Who should consider this trial

Good fit: Ideal candidates are Black/African American and Hispanic individuals aged 18 to 80 with elevated Lp(a) and established ASCVD.

Not a fit: Patients with uncontrolled hypertension, severe heart failure, or significant kidney or liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cardiovascular risk in patients with elevated Lp(a) levels.

How similar studies have performed: Other studies have shown promise in lowering Lp(a) levels, but this specific approach with pelacarsen is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 112 other locations

+63 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Elevated Lp and Established Atherosclerotic Cardiovascular DiseaseElevated LpCardiovascular diseasePelacarsen
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.