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NCT05646381

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

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-07

Study Completion Date

2030-03-12

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Stenosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind study

Study Groups

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Pelacarsen (TQJ230) 80mg

Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously

Group Type EXPERIMENTAL

Pelacarsen (TQJ230) 80mg

Intervention Type DRUG

Pelacarsen (TQJ230) 80mg

Matching placebo

Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type DRUG

Matching placebo

Interventions

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Pelacarsen (TQJ230) 80mg

Intervention Type DRUG

Matching placebo

Intervention Type DRUG

Other Intervention Names

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TQJ230 Placebo

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Heart Center Research Llc

Huntsville, Alabama, United States

Site Status RECRUITING

Cardiovascular Res Found

Beverly Hills, California, United States

Site Status RECRUITING

National Heart Institute

Beverly Hills, California, United States

Site Status RECRUITING

Flourish Clinical Resrch Covin

Covina, California, United States

Site Status RECRUITING

Valley Clinical Trials

Northridge, California, United States

Site Status RECRUITING

Stanford University Medical Center

Palo Alto, California, United States

Site Status RECRUITING

University Of California San Diego

San Diego, California, United States

Site Status RECRUITING

UC San Francisco Medical Center

San Francisco, California, United States

Site Status RECRUITING

Excel Medical Clinical Trials LLC

Boca Raton, Florida, United States

Site Status WITHDRAWN

Nova Clinical Research LLC

Bradenton, Florida, United States

Site Status RECRUITING

Flourish Res Acq LLC North Miami

Miami, Florida, United States

Site Status RECRUITING

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Site Status RECRUITING

Advanced Research for Health Improvement LLC

Naples, Florida, United States

Site Status ACTIVE_NOT_RECRUITING