Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON)

Novartis

Status and phase: Active, not recruiting; Phase 3

Conditions: Cardiovascular Disease and Lipoprotein(a)

Treatments: Drug: TQJ230; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04023552

CTQJ230A12301 (Other Identifier)

2019-001076-11 (EudraCT Number)

Details and patient eligibility

About

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Enrollment: 8,323 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
• Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Clinically significant symptomatic peripheral artery disease

Key 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 ≤LLN
• Active liver disease or hepatic dysfunction
• Significant kidney disease
• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8,323 participants in 2 patient groups, including a placebo group

TQJ230

Experimental group

Description:

TQJ230 80 mg injected monthly administered subcutaneously

Treatment:

Drug: TQJ230

Placebo

Placebo Comparator group

Description:

Monthly subcutaneous injections.

Treatment:

Drug: Placebo