A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
NCT05646381 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 502
Last updated 2026-04-15
Summary
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.
Conditions
- Aortic Stenosis
Interventions
- DRUG
-
Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
- DRUG
-
Matching placebo
Matching placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-07
- Primary Completion
- 2030-03-12
- Completion
- 2030-03-12
- FDA Drug
- Yes
Countries
- United States
- Austria
- Belgium
- Canada
- Czechia
- Denmark
- France
- Germany
- Israel
- Italy
- Netherlands
- Portugal
- Spain
- Switzerland
- United Kingdom
Study Locations
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