A Placebo-Controlled Study to Investigate the Effect of investigational study medication on the Reduction of Morbidity and Mortality in Adults with Obesity

Inclusion Criteria

In general, an individual may take part in the study if they

• Have a BMI >27.0 kg/m2
• Are either individuals 40 years of age with established cardiovascular disease >90 days prior to Visit 1, or women 55 years of age or men 50 years of age without established cardiovascular disease but have the presence of cardiovascular risk factors, such as current tobacco use, abnormal levels of fats (lipids) in the blood, high blood pressure, kidney disease, or elevated blood glucose levels.
• Are reliable and willing to make themselves available for the duration of the study, attend required study visits, and are willing and able to follow study procedures as required.

In general, an individual may not take part in the study if they

• Have a diagnosis or laboratory evidence of diabetes mellitus at screening
• Have any of the following cardiovascular conditions within 90 days prior to screening
• myocardial infarction (heart attack)
• acute coronary syndrome
• stroke
• procedure to treat coronary artery disease, or
• heart failure or signs or symptoms of heart failure requiring
• IV medication, or
•  a left ventricular assist device.
• Have a planned procedure to treat coronary artery disease
• Have uncontrolled high blood pressure
• Have had or plan to have surgery or device treatment for obesity
• Exception: Liposuction or abdominoplasty.
• Use products intended for weight loss including prescription drugs, over-the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening