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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT05646381

Run by

Novartis Pharmaceuticals

People needed

502

Starts

2024-03-07

Expected to finish

2030-03-12

Last updated by the study team

2026-06-23

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Heart Center Research Llc — Huntsville, Alabama, United States (enrolling)
• Capital Cardiology Associates — Albany, New York, United States (enrolling)
• Cardiovascular Res Found — Beverly Hills, California, United States (enrolling)
• Valley Clinical Trials — Northridge, California, United States (enrolling)
• Overlook Medical Center — Summit, New Jersey, United States (enrolling)
• University Of California San Diego — San Diego, California, United States (enrolling)
• UC San Francisco Medical Center — San Francisco, California, United States (enrolling)
• Flourish Clinical Resrch Covin — Covina, California, United States (enrolling)
• Nova Clinical Research LLC — Bradenton, Florida, United States (enrolling)
• Flourish Res Acq LLC North Miami — Miami, Florida, United States (enrolling)
• National Heart Institute — Beverly Hills, California, United States (enrolling)
• Stanford University Medical Center — Palo Alto, California, United States (enrolling)
• Midwest Heart and Vascular Spec — Overland Park, Kansas, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Womens Hosp Harvard Med School — Boston, Massachusetts, United States (enrolling)
• Brigham and Womens Hosp Harvard Med School — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• AA Medical Research Center — Flint, Michigan, United States (enrolling)
• William Beaumont Hospital — Royal Oak, Michigan, United States (enrolling)
• Inpatient Research Clinical LLC — Miami Lakes, Florida, United States (enrolling)
• University Of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Icahn School of Med at Mt Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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