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

May 27, 2026 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelacarsen
Pelacarsen (TQJ230) 80 mg s.c. QM
Drug: Pelacarsen
Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM)
Other Names:
  • TQJ230
Placebo Comparator: Placebo
Corresponding placebo s.c. QM
Drug: Placebo
Placebo subcutaneously (s.c.) once a month (QM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 180 and Day 540
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
22 months
Summary of observed values for Glomerular Filtration Rate (GFR)
Time Frame: Up to 18 months
Summary of observed values in GFR (Safety laboratory parameters)
Up to 18 months
Change from baseline in Glomerular Filtration Rate (GFR)
Time Frame: Baseline and up to 18 months
Change from baseline in GFR (Safety laboratory parameters)
Baseline and up to 18 months
Summary of observed values for Heart Rate (HR)
Time Frame: Up to 18 months
Summary of observed values for HR (electrocardiogram)
Up to 18 months
Change from baseline in Heart Rate (HR)
Time Frame: Baseline and up to 18 months
Change from baseline in HR (electrocardiogram)
Baseline and up to 18 months
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)
Up to 18 months
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)
Baseline and up to 18 months
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
Baseline and Day 540

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

December 7, 2028

Study Completion (Estimated)

December 7, 2028

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTQJ230A1US13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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