Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 144
- 主要终点
- Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
研究概览
简要总结
This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine.
Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.
During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity.
The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.
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
- Double (Participant, Investigator)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 above or equal to 18 years at the time of signing informed consent.
- •Body mass index (BMI) greater than or equal to 30.0 kg/m^2
- •New York Heart Association (NYHA) Class II-IV
- •Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening
排除标准
- •A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
研究组 & 干预措施
Semaglutide
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
干预措施: Semaglutide (Drug)
Placebo (semaglutide)
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
干预措施: Placebo (semaglutide) (Drug)
结局指标
主要结局
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
时间窗: From baseline (week 0) to end of treatment (week 52)
The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Change in Body Weight
时间窗: From baseline (week 0) to end of treatment (week 52)
Change in body weight from baseline (week 0) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
次要结局
- The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs(From baseline (week 0) to end of study (week 57))
- Change in C-Reactive Protein (CRP): Ratio to Baseline(From baseline (week -2) to end of treatment (week 52))
- Percentage of Participants Achieving 15% Weight Loss (Yes/No)(From baseline (week 0) to end of treatment (week 52))
- Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S)(From baseline (week 0) to end of treatment (week 52))
- Change in Six-minute Walking Distance (6MWD)(From baseline (week 0) to end of treatment (week 52))
- Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No)(From baseline (week 0) to end of treatment (week 52))
- Percentage of Participants Achieving 20% Weight Loss (Yes/No)(From baseline (week 0) to end of treatment (week 52))
- Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No)(From baseline (week 0) to end of treatment (week 52))
- Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No)(From baseline (week 0) to end of treatment (week 52))
- Change in Systolic Blood Pressure (SBP)(From baseline (week -2) to end of treatment (week 52))
- Change in Waist Circumference(From baseline (week 0) to end of treatment (visit 52))
- Change in KCCQ Overall Summary Score (KCCQ-OSS)(From baseline (week 0) to end of treatment (week 52))
- Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S)(From baseline (week 0) to end of treatment (week 52))