Status:

RECRUITING

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Aortic Stenosis

Eligibility:

All Genders

50-80 years

Phase:

PHASE2

Brief 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 calcifi...

Eligibility Criteria

Inclusion Criteria:

  • Male and female ≥50 to <80 years of age at Screening Part II
  • 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

Key Trial Info

Start Date :

March 7 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 12 2030

Estimated Enrollment :

502 Patients enrolled

Trial Details

Trial ID

NCT05646381

Start Date

March 7 2024

End Date

March 12 2030

Last Update

April 15 2026

Active Locations (139)

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Page 1 of 35 (139 locations)

1

Heart Center Research Llc

Huntsville, Alabama, United States, 35801

2

Cardiovascular Res Found

Beverly Hills, California, United States, 90210

3

National Heart Institute

Beverly Hills, California, United States, 90211

4

Flourish Clinical Resrch Covin

Covina, California, United States, 91723