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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.