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

Novartis

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Coronary Syndrome (ACS)

Treatments: Drug: Pelacarsen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07625306

CTQJ230A1US13

Details and patient eligibility

About

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).

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Pelacarsen

Experimental group

Description:

Pelacarsen (TQJ230) 80 mg s.c. QM

Treatment:

Drug: Pelacarsen

Placebo

Placebo Comparator group

Description:

Corresponding placebo s.c. QM

Treatment:

Drug: Placebo