EUCTR2020-004170-22-ES进行中（未招募）1 期
Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction, and type 2 diabetes - STEP HFpEF DM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 610
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female, age above or equal to 18 years at the time of signing informed consent.
- •- Body mass index (BMI) at least 30.0 kg/m^2
- •- New York Heart Association (NYHA) Class II-IV
- •- Left ventricular ejection fraction (LVEF) at least 45% at screening
- •- Diagnosed with T2D at least 90 days prior to the day of screening
- •- HbA1c of maximum 10.0% as measured at the screening visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 305
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 305
排除标准
- •- A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
研究者
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