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Clinical Trials List

Protocol NumberCTQJ230A12304
NCT Number(ClinicalTrials.gov Identfier)NCT06813911
Active

2025-07-01 - 2028-05-31

Phase III

Recruiting5

ICD-10I70.0

Atherosclerosis of aorta

ICD-9440.0

Atherosclerosis of aorta

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)

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Tzung-Dau Wang Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kang-Ling Wang Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏建勳 Division of Cardiovascular Diseases
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ping-Yen Liu
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Atherosclerotic Cardiovascular Disease (ASCVD)

Objectives

The purpose of the CTQJ230A12304 trial was to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in ASCVD participants with elevated lipoprotein (a) [Lp(a)] and background treatment against elevated low-density lipoprotein cholesterol (LDL-C) using inclisiran.

Test Drug

預充填式注射劑

Active Ingredient

pelacarsen

Dosage Form

230

Dosage

80 mg/0.8 mL

Endpoints

• Change in log-transformed Lp(a) concentration at month 6 compared to baseline

Inclution Criteria

Key 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

Key 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
Pregnant or nursing women at Screening visit
Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit

The Estimated Number of Participants

  • Taiwan

    19 participants

  • Global

    340 participants

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