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 - I8F-MC-GPIJ

Masaki Takeshi0 个研究点目标入组 15,000 人开始时间: 2022年11月26日最近更新: 2024年5月27日

试验速览

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•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
•-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
•-acute coronary syndrome
•-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.

发起方

Masaki Takeshi