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NCT Number: NCT07625306

Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL

CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in participants with elevated Lp(a) and recent acute coronary syndrome (ACS).

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This study consists of Lp(a) measurement and additional screening assessments, a double-blind treatment period of 18 months, and a 16-week safety follow up period from the last dose. Efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo will be assessed throughout the study, with primary analysis at Day 180 and final analysis at Day 540.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lp(a) ≥ 150 nmol/L
  • Within 10 days of hospitalization for ACS event and meets all of the following criteria:
  • Clinical syndrome consistent with spontaneous cardiac ischemia
  • Diagnosis of ACS: ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI)

Exclusion criteria

  • Uncontrolled hypertension
  • Heart failure New York Heart Association (NYHA) class IV
  • History of malignancy of any organs
  • History of hemorrhagic stroke or other major bleeding
  • Platelet count ≤ LLN
  • Active liver disease or hepatic dysfunction
  • Significant kidney disease
  • Contraindication for CCTA or severe contrast allergy
  • Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Pelacarsen

Drug

Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM)

Other names: TQJ230

Placebo

Drug

Placebo subcutaneously (s.c.) once a month (QM)

Primary outcomes

  1. Change in log-transformed Lp(a) concentration

    Time frame: Baseline, Day 180

    Change in log-transformed Lipoprotein A (Lp(a)) concentration from baseline to Day 180

Secondary outcomes

  1. Proportion of participants with Lp(a) < 105 nmol/L

    Time frame: Day 180 and Day 540

    Proportion of participants with Lipoprotein A (Lp(a)) < 105 nmol/L

  2. Proportion of participants with TEAEs, TESAEs,TEAEs or TESAEs leading to study drug discontinuation and TEAEs of special interest

    Time frame: 22 months

    Proportion of participants with:

    • Treatment-emergent adverse events (TEAEs)
    • Treatment-emergent serious adverse events (TESAEs)
    • TEAEs or TESAEs leading to study drug discontinuation
    • TEAEs of special interest

  3. Summary of observed values for Glomerular Filtration Rate (GFR)

    Time frame: Up to 18 months

    Summary of observed values in GFR (Safety laboratory parameters)

  4. Change from baseline in Glomerular Filtration Rate (GFR)

    Time frame: Baseline and up to 18 months

    Change from baseline in GFR (Safety laboratory parameters)

  5. Summary of observed values for Heart Rate (HR)

    Time frame: Up to 18 months

    Summary of observed values for HR (electrocardiogram)

  6. Change from baseline in Heart Rate (HR)

    Time frame: Baseline and up to 18 months

    Change from baseline in HR (electrocardiogram)

  7. Summary of observed values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Time frame: Up to 18 months

    Summary of observed values for SBP and DBP (vital signs)

  8. Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Time frame: Baseline and up to 18 months

    Change from baseline in SBP and DBP (vital signs)

  9. Change from baseline to Day 540 in non-calcified coronary plaque volume

    Time frame: Baseline and Day 540

    Change from baseline to Day 540 in non-calcified coronary plaque volume, as assessed by CCTA

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability, and Coronary Plaque Effects of Early Pelacarsen (TQJ230) Initiation in Patients in the US With Elevated Lp(a) and Recent Acute Coronary Syndrome

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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