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

NCT07625306 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CTQJ230A1US13
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Acute Coronary Syndrome (ACS)

Keywords

Lipoprotein(a); ASCVD; Acute Coronary Syndrome (ACS); STEMI; NSTEMI; pelacarsen (TQJ230)

Outcome Measures

Primary Outcomes (1)

• Change in log-transformed Lp(a) concentration

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

  Baseline, Day 180

Secondary Outcomes (9)

• Proportion of participants with 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

  22 months

• Summary of observed values for Glomerular Filtration Rate (GFR)

  Up to 18 months

• Change from baseline in Glomerular Filtration Rate (GFR)

  Baseline and up to 18 months

• Summary of observed values for Heart Rate (HR)

  Up to 18 months

Study Arms (2)

Pelacarsen

EXPERIMENTAL

Pelacarsen (TQJ230) 80 mg s.c. QM

Drug: Pelacarsen

Placebo

PLACEBO COMPARATOR

Corresponding placebo s.c. QM

Drug: Placebo

Interventions

Pelacarsen DRUG

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

Also known as: TQJ230

Pelacarsen

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

pelacarsen

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 7, 2028
• Study Completion (Estimated): December 7, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share