jRCT2031220466进行中（未招募）不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,000
- 主要终点
- Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 40age old over 至 No limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)
时间窗: Up to 5 Years
Time to first occurrence of any component event of composite, all-cause death, nonfatal MI, nonfatal stroke, coronary revascularization, or heart failure events that results in hospitalization or urgent visits.
次要结局
未报告次要终点
研究者
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