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Lowering Lipoprotein(a) to Slow Aortic Valve Stenosis Progression

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]

PHASE2 · Novartis · NCT05646381

This study is testing if a monthly injection of a new drug can help slow down the worsening of aortic valve narrowing in adults aged 50 to 80 who have high lipoprotein(a) levels.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment502 (estimated)
Ages50 Years to 80 Years
SexAll
SponsorNovartis (industry)
Locations139 sites (Huntsville, Alabama and 138 other locations)
Trial IDNCT05646381 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of pelacarsen (TQJ230), administered subcutaneously once a month, in slowing the progression of calcific aortic valve stenosis compared to a placebo. Participants will be adults aged 50 to 80 with elevated lipoprotein(a) levels and mild to moderate aortic stenosis. The study aims to determine if lowering lipoprotein(a) can positively impact the condition's progression. The trial is interventional and is conducted across multiple centers.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 50 to 80 with mild to moderate calcific aortic valve stenosis and elevated lipoprotein(a) levels.

Not a fit: Patients with severe calcific aortic valve stenosis or uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly slow the progression of aortic valve stenosis, improving patient outcomes and quality of life.

How similar studies have performed: While the approach of targeting lipoprotein(a) is relatively novel, similar studies have shown promise in cardiovascular interventions.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Huntsville, Alabama and 138 other locations

+89 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aortic Stenosis, Cardiovascular, Lipoprotein, Lp, Hyperlipoproteinemia, Calcific aortic valve stenosis, TQJ230, Pelacarsen

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.