Obesity Overweight
Conditions
Interventions
-Drug: Tirzepatide
Administered SC
Other Name: LY3298176
-Drug: Placebo
Administered SC
Study Arms
-Experimental: Tirzepatide
Participants will receive escalated doses of tirzepatide
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) [ Time Frame: 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. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed