A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,531
- 试验地点
- 1,066
- 主要终点
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)
研究概览
简要总结
This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet.
The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight.
Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity.
Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years.
- •Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.
- •Further inclusion criteria apply.
排除标准
- •Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
- •Type 1 diabetes.
- •Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening.
- •Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
- •Further exclusion criteria apply.
研究组 & 干预措施
survodutide 3.6 mg
干预措施: survodutide (Combination Product)
survodutide 6.0 mg
干预措施: survodutide (Combination Product)
Placebo
干预措施: Placebo (Combination Product)
结局指标
主要结局
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)
时间窗: up to Week 114
Heart failure events (HFE) includes hospitalisation for heart failure (HHF), emergency room visit, urgent care visit, or urgent outpatient heart failure (HF) visit (5-point major adverse cardiac event (5P-MACE)) CV-Cardiovascular MI-Myocardial infarction
次要结局
- Time to first occurrence of adjudicated CV death or adjudicated HFE(up to Week 114)
- Time to first occurrence of adjudicated CV death or adjudicated HHF(up to Week 114)
- Time to first occurrence of adjudicated HFE(up to Week 114)
- Time to adjudicated CV death(up to Week 114)
- Time to all-cause mortality(up to Week 114)
- Time to first occurrence of adjudicated non-fatal MI(up to Week 114)
- Time to first occurrence of adjudicated non-fatal stroke(up to Week 114)
- Time to first occurrence of adjudicated ischaemia related coronary revascularisation(up to Week 114)
- Achievement of body weight reduction ≥5% from baseline to Week 72(Baseline and at Week 72)
- Achievement of body weight reduction ≥10% from baseline to Week 72(Baseline and at Week 72)
- Achievement of body weight reduction ≥15% from baseline to Week 72(Baseline and at Week 72)
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE))(up to Week 114)
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE)(up to Week 114)
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority)(up to Week 114)
- Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72(Baseline and at Week 72)
- Absolute change in waist circumference (cm) from baseline to Week 72(Baseline and at Week 72)
- Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline(At Baseline and at Week 72)
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority)(up to Week 114)
- Percentage change in body weight from baseline to Week 72(Baseline and at Week 72)
- Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72(Baseline and at Week 72)
- Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72(Baseline and at Week 72)
- Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72(Baseline and at Week 72)
- Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)(Baseline and at Week 72)
- Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM(Baseline and at Week 72)
- Time to onset of T2DM in trial participants without T2DM at baseline(up to Week 114)
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE)(up to Week 114)
- A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline(At baseline and at 72 Weeks)