CTRI/2023/04/051445进行中（未招募）3 期
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
Eli Lilly and Company India Pvt Ltd11 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2023年10月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15,000
- 试验地点
- 11
- 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
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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: 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.
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 -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
- •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
次要结局
- Hierarchical Composite of Renal Death or End-Stage Renal Disease (ESRD), Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), and eGFR Slope(Baseline (Week 0) to Study Completion up to 5 Years.)
- Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score(Baseline, 2 Years)
- 1. Percent Change from Baseline in Body Weight(2. Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg))
- 1. Time to Onset of Type 2 Diabetes (T2D)(2. Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke))
研究者
研究点 (11)
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