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Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)

NCT06813911•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants 18 to ≤80 years of age at Screening visit
•Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
•On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
•Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
•On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
•Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
•Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit

Exclusion Criteria

•Prior treatment with inclisiran
•Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
•Uncontrolled hypertension at Randomization/Baseline visit
•Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
•Triglycerides ≥400 mg/dL at Screening visit
•History of malignancy of any organ system within the past 5 years
•Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
•Central laboratory reported platelet count \<140,000 per mm3
•Active liver disease or hepatic dysfunction at Screening visit
•Significant kidney disease at Screening visit
+2 more criteria

Locations (80)

Parkway Medical Center

Birmingham, Alabama, United States

Clinical Research Inst of Arizona

Sun City West, Arizona, United States

National Heart Institute

Beverly Hills, California, United States

Interv Cardiology Med Grp

West Hills, California, United States

Excel Medical Clinical Trials LLC

Boca Raton, Florida, United States

Jacksonville Center for Clinical

Jacksonville, Florida, United States

K2 Medical Research LLC

Maitland, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Miami Cancer Institute at Bapt

Miami, Florida, United States

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Key Dates

Start Date

April 30, 2025

Primary Completion Date

February 3, 2028

Completion Date

February 29, 2028

Last Updated

March 12, 2026

Enrollment

340

ESTIMATED participants

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)

Interventions

Pelacarsen

DRUG

Placebo

DRUG

Inclisiran

DRUG

Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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