Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD

Purpose

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Condition

  • Cardiovascular Disease and Lipoprotein(a)

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory - Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit - Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit - Clinically significant symptomatic peripheral artery disease

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 ≤LLN - Active liver disease or hepatic dysfunction - Significant kidney disease - Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply at the end.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
  • Drug: TQJ230
    TQJ230 80 mg injected monthly administered subcutaneously
Placebo Comparator
Placebo
Monthly subcutaneous injections.
  • Drug: Placebo
    Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
    Other names:
    • Placebo to match TQJ230

Recruiting Locations

Novartis Investigative Site
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com