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

• Status: Not yet recruiting
• Trial end date: 2028-01-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male and female ≥50 years of age

• Lp(a) ≥125 nmol/L at the screening visit, measured at the Central laboratory

• Mild or moderate calcific aortic valve stenosis

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