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
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
This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.
Inclusion 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:
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
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
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.
Gilbert, Arizona 85296, United States
Torrance, California 90502, United States
Springfield, Illinois 62711, United States
Troy, Michigan 48098, United States
Pittsburgh, Pennsylvania 15243, United States
North Richland Hills, Texas 76180, United States
Wenatchee, Washington 98801, United States
C.a.b.a., C1205AAO, Argentina
CABA, C1060ABN, Argentina
CABA, C1061AAS, Argentina
Capital, X5008HHW, Argentina
Rosario, 2000, Argentina
SAN M. de Tucuman, T4000AXL, Argentina
North York, M6B 3H7, Canada
Hengshui Shi, 053000, China
Luoyang Shi, 471003, China
Paris, 75010, France
Saint Ingbert, 66386, Germany
Villingen-Schwenningen, 78048, Germany
Thermi,Thessaloniki, 570 01, Greece
Palermo, 90127, Italy
Onga-gun, 807-0051, Japan
Culiacán, 80230, Mexico
Mexico City, 11650, Mexico
Bialystok, 15445, Poland
Kaohsiung Niao Sung Dist, 83301, Taiwan
Kadıköy, 34722, Turkey (Türkiye)