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

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]

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05646381

Enrollment

502

Registered

2022-12-12

Start date

2024-03-07

Completion date

2030-03-12

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Cardiovascular, Lipoprotein(a), Lp(a), Hyperlipoproteinemia(a), Calcific aortic valve stenosis, TQJ230, Pelacarsen, Aortic valve stenosis, Aortic stenosis

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 calcific aortic valve stenosis.

Interventions

DRUGPelacarsen (TQJ230) 80mg

Pelacarsen (TQJ230) 80mg

DRUGMatching placebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-blind study

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
Change in peak aortic jet velocity	36 months	To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
Change in aortic valve calcium score	36 months	To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography

Secondary

Measure	Time frame	Description
Change in Lp(a) levels	12 months	To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
Change in fibrocalcific thickening of the aortic valve	36 months	To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT
Time from randomization to first occurrence of composite clinical endpoint event	Up to 36 months	To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either: 1. Unplanned CAVS related hospital admission 2. Aortic valve intervention 3. Death related to calcific aortic valve stenosis

Countries

Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States

Contacts

CONTACTNovartis Pharmaceuticals

novartis.email@novartis.com1-888-669-6682

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026