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

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

First listed
Mar 31, 2022
Start date
Aug 19, 2022
Status verified
Jul 2026
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)
    Pelacarsen (TQJ230) 80 mg s.c. Q4W
  • Placebo Comparator: Placebo
    Placebo to Pelacarsen s.c. Q4W

Primary Outcome Measure

Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule [ Time Frame: Up to Week 52 ]

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