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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-19

Study Completion Date

2025-01-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hyperlipoproteinemia(a)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pelacarsen (TQJ230)

Group Type EXPERIMENTAL

Pelacarsen (TQJ230) 80 mg s.c.

Intervention Type DRUG

Pelacarsen (TQJ230) 80 mg s.c. Q4W

Placebo

Group Type PLACEBO_COMPARATOR

Corresponding Placebo

Intervention Type DRUG

Placebo to Pelacarsen

Interventions

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Pelacarsen (TQJ230) 80 mg s.c.

Pelacarsen (TQJ230) 80 mg s.c. Q4W

Intervention Type DRUG

Corresponding Placebo

Placebo to Pelacarsen

Intervention Type DRUG

Other Intervention Names

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TQJ230 Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No