NCT07670884招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 675
- 试验地点
- 2
- 主要终点
- Percentage change from baseline in body weight after 52 weeks of treatment
研究概览
简要总结
This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 18-75 years of age at the time of signing informed consent;
- •At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
- •Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
- •Able and willing to provide a written informed consent.
排除标准
- •Presence of clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
- •Uncontrollable severe hypertension;
- •PHQ-9 score ≥ 15;
- •Medical history or illness that affects body weight;
- •History of diabetes;
- •Acute or chronic hepatitis;
- •History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- •Any organ-system malignancies developed within 5 years;
- •Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;
- •Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;
- •Use of any medication or treatment that may have caused significant weight change within 90 days;
- •History of bariatric surgery;
- •Known or suspected hypersensitivity to trial product(s) or related products;
- •History of alcohol and/or substance abuse or drug abuse;
- •History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- •Surgery is planned during the trial;
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
HRS9531 Tablet Group
Experimental
HRS9531 tablet.
干预措施: HRS9531 Tablet (Drug)
HRS9531 Tablet Placebo Group
Placebo Comparator
HRS9531 tablet placebo.
干预措施: HRS9531 Tablet Placebo (Drug)
结局指标
主要结局
Percentage change from baseline in body weight after 52 weeks of treatment
时间窗: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment
时间窗: After 52 weeks of treatment.
次要结局
- Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment(After 52 weeks of treatment.)
- Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment(After 52 weeks of treatment.)
- Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in waist circumference after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in body weight after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in blood pressure after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in fasting plasma glucose after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in fasting serum insulin after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in glycosylated hemoglobin after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in blood lipid after 52 weeks of treatment(After 52 weeks of treatment.)
- Change from baseline in blood uric acid after 52 weeks of treatment(After 52 weeks of treatment.)
- Number of treatment serious adverse events (SAEs) within 57 weeks(Within 57 weeks.)
- Number of treatment adverse events (AEs) within 57 weeks(Within 57 weeks.)
研究者
研究点 (2)
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