A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Purpose
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.
Condition
- Aortic Stenosis
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male and female ≥50 to <80 years of age - Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory - Mild or moderate calcific aortic valve stenosis - At the randomization visit, participant must be optimally treated for existing CV risk factors
Exclusion Criteria
- Severe calcific aortic valve stenosis - Uncontrolled hypertension - History of malignancy of any organ system - History of hemorrhagic stroke or other major bleeding - Platelet count ≤ LLN - Active liver disease or hepatic dysfunction - Significant kidney disease - Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Double-blind study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Pelacarsen (TQJ230) 80mg |
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously |
|
|
Placebo Comparator Matching placebo |
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals