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Clinical Trials List

Protocol NumberI8F-MC-GPGN
NCT Number(ClinicalTrials.gov Identfier)NCT04255433
Completed

2020-05-29 - 2025-06-12

Phase III

Recruiting1

Terminated8

The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT).

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator I-TE LEE Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases

Co-Principal Investigator

  • 王朝永 Division of Cardiovascular Diseases
  • 何明昀 Division of Cardiovascular Diseases
  • 陳東藝 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases
  • 陳俊吉 Division of Cardiovascular Diseases
  • 葉日凱 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃偉輔 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 杜思德 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ting-Hsing Chao Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳榮福 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 劉銘恩 Division of Cardiovascular Diseases

Co-Principal Investigator

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

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 王志鴻 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Type 2 Diabetes Mellitus

Objectives

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Test Drug

Tirzepatide (LY3298176)

Active Ingredient

LY3298176 (Tirzepatide)

Dosage Form

Injection

Dosage

2.5mg/5mg/7.5mg/ 10mg, 12.5mg/ 15mg

Endpoints

Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3) [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]

Inclution Criteria

1. Have a diagnosis of type 2 diabetes
2. Have confirmed atherosclerotic cardiovascular disease
3. HbA1c ≥7.0% to ≤10.5%
4. Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

Exclusion Criteria

1.Have had a major cardiovascular event within the last 60 days
2.Have type 1 diabetes mellitus
3.Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
4.Are currently planning treatment for diabetic retinopathy and/or macular edema
5.Currently planning a coronary, carotid, or peripheral artery revascularization
6.Have a history of pancreatitis
7.Have a history of ketoacidosis or hyperosmolar state/coma
8.Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
9.Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
10.Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
11.Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement

The Estimated Number of Participants

  • Taiwan

    180 participants

  • Global

    13299 participants