NCT06391710进行中（未招募）2 期
A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
研究概览
简要总结
This was a multicenter, randomized, double-blind, placebo-parallel-controlled Phase II clinical study to evaluate the efficacy and safety of HRS9531 Injection compared to placebo in obese subjects with heart failure with preserved ejection fraction.
A total of 200 obese subjects with heart failure with preserved ejection fraction would be enrolled. Eligible subjects were randomly assigned to either HRS9531 group or placebo group and were treated with HRS9531 injection or placebo, respectively, for 52 weeks.
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 above or equal to 18 years at the time of signing informed consent.
- •Body mass index (BMI) greater than or equal to 28.0 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
- •Medical history of myocardial infarction, acute decompensated heart failure, heart failure requiring hospitalization or urgent heart failure visit, unstable angina, stroke, or transient ischemic attack within 30 days prior to or at screening;
- •Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.
研究组 & 干预措施
HRS9531
Experimental
干预措施: HRS9531 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
时间窗: From baseline (week 0) to week 36
Change in body weight
时间窗: From baseline (week 0) to week 36
次要结局
- Hierarchical composite of time to all-cause death(From baseline (week 0) to week 36,52)
- Hierarchical composite of time to the first heart failure events requiring hospitalisation or urgent heart failure visit(From baseline (week 0) to week 36,52)
- Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit(From baseline (week 0) to week 36,52)
- Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 36, 52 weeks(From baseline (week 0) to week 36,52)
- Change in KCCQ clinical summary score(From baseline (week 0) to week 52)
- Change in body weight(From baseline (week 0) to week 52)
- Change in C-Reactive Protein (CRP)(From baseline (week 0) to week 36,52)
- Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)(From baseline (week 0) to week 36,52)
研究者
研究点 (1)
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