JPRN-jRCT2031230478招募中3 期
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 - SYNCHRONIZE - CVOT
Yamamoto Machiko0 个研究点目标入组 4,935 人开始时间: 2023年11月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4,935
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. 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.
- •2. 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.
排除标准
- •1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1)agonists within 3 months before screening.
- •2. Type 1 diabetes.
- •3. 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.
- •4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
研究者
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