NCT05556512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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 15,374
- 试验地点
- 1,280
- 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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.
研究组 & 干预措施
Tirzepatide
Experimental
Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.
干预措施: Tirzepatide (Drug)
Placebo
Placebo Comparator
Participants will receive tirzepatide matched placebo.
干预措施: Placebo (Drug)
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
- Time to Onset of Type 2 Diabetes (T2D)(Up to 5 Years)
- Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)(Up to 5 Years)
- Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)(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)
- Time to the Occurrence of All-cause Death(Up to 5 Years)
- Time to First Occurrence of CV Death(Up to 5 Years)
- Time to First Occurrence of MI(Up to 5 Years)
- Time to First Occurrence of Stroke(Up to 5 Years)
- Time to First Occurrence of Coronary Revascularization(Up to 5 Years)
- Time to First Occurrence Heart Failure (HF) Events(Up to 5 Years)
- Time to First Occurrence of Hospitalization for Unstable Angina(Up to 5 Years)
- Time to first occurrence of Hospitalization or Urgent Visit(Up to 5 Years)
- Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death)(Up to 5 Years)
- Percent Change from Baseline in Body Weight(Baseline, 156 Weeks)
- Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)(Baseline, 156 Weeks)
- Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)(Baseline, 156 Weeks)
- Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%)(Up to 5 Years)
- Time to First Occurrence of Any Component Event of Composite Endpoint (All-Cause Death, Nonfatal MI, Nonfatal Stroke, Coronary Revascularization, Heart Failure Events, > 40% Sustained Decline in eGFR, or End Stage Renal Disease)(Up to 5 Years)
研究者
研究点 (1280)
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