Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesityrelatedheart failure with preserved ejection fraction, and type 2 diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 610
- 试验地点
- 9
- 主要终点
- 1- Change in KCCQ clinical summary
研究概览
简要总结
This is a 52-week, randomised, placebo-controlled, double-blinded, multi-centre clinical trial comparing semaglutide s.c. 2.4 mg with placebo in subjects with obesity-related HFpEF and T2D.
Eligible subjects will be randomised in a 1:1 manner to receive either semaglutide s.c. 2.4 mg or placebo once-weekly as add-on to standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 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) ≥ 30.0 kg/m2 New York Heart Association (NYHA) Class II-IV Left ventricular ejection fraction (LVEF) ≥ 45% at screening Diagnosed with T2D ≥ 90 days prior to the day of screening HbA1c of ≤ 10.0% as measured at the screening visit.
排除标准
- •A self-reported change in body weight > 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.
结局指标
主要结局
1- Change in KCCQ clinical summary
时间窗: 1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %
score
时间窗: 1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %
2- Change in body weight
时间窗: 1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %
The 6MWT must be performed in accordance with the manual provided by Novo Nordisk
时间窗: 1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %
次要结局
- Change in C-Reactive Protein(From baseline (week -2) to end of treatment (week 52))
- Change in 6-minute walking distance(From baseline (week 0) to end of)