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

Prior treatment

• 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.

Other illness

• Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
• 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 a presence or history of malignant neoplasms within the past 5 years prior to screening.

Lab values

• 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).
• 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 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.