問卷

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberI8F-MC-GPIJ
NCT Number(ClinicalTrials.gov Identfier)NCT05556512
Active

2022-10-01 - 2027-12-31

Phase III

Not yet recruiting2

Recruiting9

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 呂介華

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 施志遠

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 彭渝森

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方志元

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉銘恩

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Overweight

Objectives

This trial will investigate the effect of tirzepatide on reducing morbidity and mortality in obese adults and provide additional evidence of the potential clinical benefit of tirzepatide in this population.

Test Drug

Tirzepatide(LY3298176)

Active Ingredient

Tirzepatide(LY3298176)

Dosage Form

Injection

Dosage

2.5MG、5MG、7.5MG、10MG、12.5MG、15MG

Endpoints

The time until the first occurrence of any component event in the composite indicator
‧ Death from all causes
‧ Non-fatal myocardial infarction (MI)
‧ Non-fatal stroke
‧ Coronary artery revascularization, or
‧ Heart failure events leading to hospitalization or emergency medical attention

Inclution Criteria

Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²)
Are either

individuals ≥40 years of age with established cardiovascular disease (CVD).

CVD is defined as meeting at least one of the following:

Coronary artery disease
Cerebrovascular disease
Peripheral arterial disease OR
individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention)
women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or

women ≥70 years of age or men, ≥65 years of age with at least 2 risk factors at screening.

Exclusion Criteria

Exclusion Criteria:

Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c ≥6.5% (≥48 millimole/mole (mmol/mol) or fasting glucose (FG) ≥126 milligram/deciliter (≥7.0 millimole/liter (mmol/L).
Any one of the following CV conditions within 90 days prior to screening

MI
acute coronary syndrome
stroke
coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or
acute decompensated heart failure
Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.
Have a history of chronic or acute pancreatitis
Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening
Have a presence or history of malignant neoplasms within the past 5 years prior to screening.

The Estimated Number of Participants

  • Taiwan

    320 participants

  • Global

    15000 participants