NCT07141914已完成不适用
A Master Protocol for Semaglutide Effects on Cardiovascular and Obesity-related Outcomes in People With Overweight or Obesity in the Real World
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285,327
- 试验地点
- 1
- 主要终点
- Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event)
研究概览
简要总结
This study aims to evaluate the association of once-weekly semaglutide with the risk of cardiovascular (CV) and other obesity-related clinical outcomes in three study populations (Heart failure (HF), clinical Atherosclerotic Cardiovascular Disease (ASCVD), primary prevention).
This is a retrospective cohort study which includes administrative medical and pharmacy claims linked with clinical and laboratory measurements for participants in the US during January 1, 2016 - December 31, 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with overweight or obesity defined as at least one overweight/obesity indication of a specified body mass index (BMI) more than or equal to (≥) 27.0 kilogram per meter square (kg/m2) and undefined obesity indications, defined by diagnoses and laboratory values, during January 1, 2016 to December 31, 2024
- •Participants with a record indicating the study population of interest during January 1, 2016 to December 31, 2024
- •1. HF: Diagnosis of HF
- •Clinical ASCVD: Diagnosis or procedure codes indicating:Coronary artery disease (CAD) including acute coronary syndrome (ACS; i.e., myocardial infarction [MI] or unstable angina), stable angina, coronary or other arterial revascularization or intervention, ischemic stroke, transient ischemic attack (TIA), carotid or other arterial stenosis, peripheral arterial disease (PAD) including aortic aneurysm
- •Primary Prevention: Patients at risk for developing ASCVD defined as the presence of more than or equal to (≥) 3 of the following risk factors
- •Smoking history
- •Dyslipidaemia
- •Hypertension
- •Prediabetes
- •Chronic kidney disease (CKD) or evidence of kidney function decline/kidney damage
- •High-sensitivity C-reactive protein (hs-CRP) more than or equal to (≥) 2 milligram per litre (mg/L)
- •3. Participants who are more than or equal to (≥) 45 years old by December 31, 2024
- •4. Participants will be divided into the following groups: those who initiate semaglutide on or after the eligibility date and June 4, 2021 (semaglutide users; date of initiation termed the index date) or participants with no evidence of semaglutide usage during January 1, 2016 to December 31, 2024 (non-users; a randomly selected date with ≥ 1 pharmacy claim on or after the eligibility date and June 4, 2021 will be termed the index date)
- •5. Participant with continuous insurance enrolment eligibility more than or equal to (≥) 12 months prior to the index date (the baseline period)
- •6. Participants with re-confirmed overweight/obesity indication during the baseline period
排除标准
- •1. Population specific exclusion criteria:
- •HF and Clinical ASCVD Populations: Diagnosis of end-stage HF
- •Primary Prevention Population: Diagnosis of HF or haemorrhagic stroke, or evidence of clinical ASCVD
- •2. Participants with a diagnosis of chronic or acute pancreatitis
- •3. Participants with a diagnosis of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •4. Participants with end-stage kidney disease (ESKD) including chronic or intermittent haemodialysis or peritoneal dialysis and/or kidney transplant
- •5. More than or equal to (≥ 2) diagnoses of cancer (excluding non-melanoma skin cancer)
- •6. Pregnancy in female participants
- •7. Evidence of diabetes including more than or equal to (≥) 2 diagnoses of type 1 diabetes or more than or equal to (≥) 2 diagnoses of type 2 diabetes on distinct dates, use of a glucose-lowering agent, and/or glycated haemoglobin (HbA1c) laboratory result more than or equal to ≥ 6.5 percent (%)
- •8. Use of a glucagon-like peptide-1 (GLP-1) or GLP-1/gastric inhibitory polypeptide (GIP) receptor agonist approved for weight management during the baseline period
- •9. Participants with evidence of bariatric surgery
研究组 & 干预措施
Cohort: Semaglutide users
干预措施: No treatment given (Other)
Cohort: Semaglutide Non-users
干预措施: No treatment given (Other)
结局指标
主要结局
Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event)
时间窗: Index date, earliest of revised MACE-5 and end of follow-up; up to 42 months
Measured as Months Occurrence of any of the following individual component events: 1. Myocardial infarction (MI) 2. Stroke 3. Hospitalization for HF 4. Coronary revascularization (including coronary artery bypass grafting and percutaneous coronary intervention) 5. All-cause mortality The event date will be the earliest occurrence of one of the individual components.
Revised 3-point Major Adverse Cardiovascular Events MACE-3 (time-to-event)
时间窗: Index date, earliest of revised MACE-3 and end of follow-up; up to 42 months
Measured in Months Occurrence of any of the following individual component events: 1. MI 2. Stroke 3. All-cause mortality The event date will be the earliest occurrence of one of the individual components.
次要结局
- MI (time-to-event)(Index date, earliest of MI and end of follow-up; up to 42 months)
- Stroke (time-to-event)(Index date, earliest of stroke and end of follow-up; up to 42 months)
- Hospitalization for HF (time-to-event)(Index date, earliest of hospitalization for HF and end of follow-up; up to 42 months)
- Coronary revascularization (time-to-event)(Index date, earliest of Coronary revascularization and end of follow-up; up to 42 months)
- All-cause mortality (time-to-event)(Index date, end of follow-up; up to 42 months)
- MACE-5 (time-to-event)(Index date, earliest of MACE-5 and end of follow-up; up to 42 months)
- MACE-3 (time-to-event)(Index date, earliest of MACE-3 and end of follow-up; up to 42 months)
- CV-related mortality (time-to-event)(Index date, end of follow-up; up to 42 months)
- Urgent HF visit (time-to-event)(Index date, earliest of urgent HF visit and end of follow-up; up to 42 months)
- 3-point HF (time-to-event)(Index date, earliest of 3-point HF composite outcome and end of follow-up; up to 42 months)
- 2-point HF (time-to-event)(Index date, earliest of 2-point HF composite outcome and end of follow-up; up to 42 months)
研究者
研究点 (1)
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