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Clinical Trials List

Protocol NumberEX6018-4758
NCT Number(ClinicalTrials.gov Identfier)NCT05021835
Active

2021-09-01 - 2027-03-31

Phase III

Recruiting9

Terminated3

ICD-10I70.0

Atherosclerosis of aorta

ICD-9440.0

Atherosclerosis of aorta

ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

  • Trial Applicant

    NOVO NORDISK PHARMA (TAIWAN) LTD.

  • Sponsor

    Novonordisk

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Tzung-Dau Wang 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Hsing Chao 無
National Taiwan University 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 I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

  • 陳東藝 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases
  • 王朝永 Division of Cardiovascular Diseases
  • 陳俊吉 Division of Cardiovascular Diseases
  • 盧政諱 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉銘恩 Division of Cardiovascular Diseases
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

  • 林柏霖 Division of Cardiovascular Diseases
  • 楊翔惟 Division of Cardiovascular Diseases
  • 吳敘平 Division of Cardiovascular Diseases
  • 劉俞旻 Division of Cardiovascular Diseases
  • 賴堯暉 Division of Cardiovascular Diseases
  • 陳永強 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張鴻猷 Division of Cardiovascular Diseases
Cheng Hsin General Hospital

Co-Principal Investigator

  • 馮安寧 Division of Cardiovascular Diseases
  • 楊尚峯 Division of General Internal Medicine
  • 王耀章 Division of Cardiovascular Diseases
  • 傅浩能 Division of Cardiovascular Diseases
  • 馮文楷 Division of Cardiovascular Diseases
  • 鄧欣一 Division of Cardiovascular Diseases
  • 曹殿萍 Division of Cardiovascular Diseases
  • 劉怡凡 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曹玄明 Division of Cardiovascular Diseases
National Yang-Ming University Hospital

Co-Principal Investigator

  • 廖照峰 Division of Cardiovascular Diseases
  • 陳忠佑 Division of Cardiovascular Diseases
  • 陳思穎 Division of Cardiovascular Diseases
  • 黃嵩豪 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsi-Hsien Chen Division of Nephrology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Zhih-Cherng Chen Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 李統立 Division of Cardiovascular Diseases
E-DA Hospital

Co-Principal Investigator

  • 宣錦峰 Division of Cardiovascular Diseases
  • 梁懷文 Division of Cardiovascular Diseases
  • 曾維功 Division of Cardiovascular Diseases
  • 蔡幸珊 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 曹玄明 Division of Cardiovascular Diseases
國立陽明交通大學附設醫院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

ASCVD, CKD and systemic inflammation

Objectives

Primary objective: To demonstrate the superiority of ziltivekimab 15 mg s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD) and systemic inflammation.

Test Drug

Ziltivekimab B 15 mg/ml / placebo

Active Ingredient

Ziltivekimab B / placebo

Dosage Form

prefilled syringe

Dosage

15 mg/ml

Endpoints

Primary endpoint(s): Time to first occurrence of 3-point MACE, a composite endpoint consisting of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke.

Inclution Criteria

• eGFR ≥15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
• Serum hs-CRP ≥2 mg/L at screening (visit 1)
• Evidence of ASCVD by one or more of the following within the last 5 years from screening

Exclusion Criteria

Main exclusion criteria:
• Absolute neutrophil count <2×109/L at screening (Visit 1)
• Platelet count <120×109/L at screening (Visit 1)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × upper limit of normal at screening (Visit 1)
• HbA1C ≥10% (≥86 mmol/mol) at screening (Visit 1)
• Diagnosis of human immunodeficiency virus (HIV) and not receiving a stable antiretroviral regimen, at the discretion of the investigator at screening (visit 1)

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    6200 participants

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