A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity (I8F-MC-GPIJ)

Active, not recruiting

• Conditions: Obesity Overweight

• Registration Number: jRCT2031220466
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-26
• Study Start: 2022-12-19
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

-Have a body mass index (BMI) >=27.0 kilogram/square meter (kg/m2) -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

-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.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)	Up to 5 Years	Time to first occurrence of any component event of composite, all-cause death, nonfatal MI, nonfatal stroke, coronary revascularization, or heart failure events that results in hospitalization or urgent visits.