Aventiv Research | Aventiv Research Columbus
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Primary purpose
Allocation
Interventional model
Masking
15,374 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal