A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
- Conditions
- Obesity Overweight
- Registration Number
- JPRN-jRCT2031220466
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15000
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method