A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Aortic Stenosis

Treatments: Drug: Matching placebo; Drug: Pelacarsen (TQJ230) 80mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05646381

CTQJ230A12203

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Enrollment: 502 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female ≥50 to <80 years of age
• Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
• Mild or moderate calcific aortic valve stenosis
• At the randomization visit, participant must be optimally treated for existing CV risk factors

Exclusion criteria

• Severe calcific aortic valve stenosis
• Uncontrolled hypertension
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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502 participants in 2 patient groups, including a placebo group

Pelacarsen (TQJ230) 80mg

Experimental group

Description:

Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously

Treatment:

Drug: Pelacarsen (TQJ230) 80mg

Matching placebo

Placebo Comparator group

Description:

Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously

Treatment:

Drug: Matching placebo