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

Sponsor: Novartis Pharmaceuticals
Study ID: NCT05305664
Phase: PHASE3
Status: Completed

Conditions

Hyperlipoproteinemia(a)

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

Pelacarsen (TQJ230) 80 mg s.c. — DRUG
Pelacarsen (TQJ230) 80 mg s.c. Q4W
Corresponding Placebo — DRUG
Placebo to Pelacarsen

Study Details

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.

Key Dates

Start date: Aug 19, 2022
Status verified: Feb 2025
Primary completion: Jan 28, 2025
Completion: Jan 28, 2025

Study Design

Enrollment: 51 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Pelacarsen (TQJ230)
Placebo Comparator: Placebo

Primary Outcome Measure

Rate of lipoprotein apheresis sessions performed over 52 weeks normalized to the weekly lipoprotein apheresis schedule [ Time Frame: Over 52 Weeks ]