A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany

Novartis

Status and phase: Completed; Phase 3

Conditions: Hyperlipoproteinemia(a)

Treatments: Drug: Pelacarsen (TQJ230) 80 mg s.c.; Drug: Corresponding Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05305664

2021-003059-41 (EudraCT Number)

CTQJ230A12302

Details and patient eligibility

About

Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.

Full description

Lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (CV) risk reduction in patients with severely elevated Lp(a) levels in Germany. Lipoprotein apheresis is an expensive, burdensome, and time-consuming procedure. The current study (CTQJ230A12302) will investigate if treatment with pelacarsen (TQJ230) 80 mg Q4W vs placebo reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia(a) and established CV disease

Enrollment: 51 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 40 sessions within the past 52 weeks prior to randomization
• Lipoprotein(a) (Lp(a))> 60 mg/dL at screening
• Spontaneous prior myocardial infarction (MI): ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
• Ischemic stroke: ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
• Clinically significant symptomatic peripheral artery disease (PAD)

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 <140,000 per mm3 at screening
• Active liver disease or hepatic dysfunction
• Significant kidney disease
• Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

Pelacarsen (TQJ230)

Experimental group

Treatment:

Drug: Pelacarsen (TQJ230) 80 mg s.c.

Placebo

Placebo Comparator group

Treatment:

Drug: Corresponding Placebo