NCT05881837已完成2 期
A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 26
- 主要终点
- Percentage change in body weight
研究概览
简要总结
To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent;
- •Male or female subjects, 18-65 years of age at the time of signing informed consent;
- •At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
- •Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
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 hypertension;
- •PHQ-9 score ≥15;
- •Medical history or illness that affects your weight;
- •History of diabetes;
- •Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
- •History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- •Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
- •Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
- •History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
- •Use of any medication or treatment that may have caused significant weight change within 3 months;
- •History of bariatric surgery;
- •Known or suspected hypersensitivity to trial product(s) or related products;
- •Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;
- •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;
- •Mentally incapacitated or speech-impaired;
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
- •Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
研究组 & 干预措施
Treatment group A
Experimental
HRS9531 injection
干预措施: HRS9531 injection (Drug)
Treatment group B
Experimental
HRS9531 injection
干预措施: HRS9531 injection (Drug)
Treatment group C
Experimental
HRS9531 injection
干预措施: HRS9531 injection (Drug)
Treatment group D
Experimental
HRS9531 injection
干预措施: HRS9531 injection (Drug)
Treatment group E
Placebo Comparator
HRS9531 injection Placebo
干预措施: HRS9531 injection Placebo (Drug)
Treatment group F
Placebo Comparator
HRS9531 injection Placebo
干预措施: HRS9531 injection Placebo (Drug)
Treatment group G
Placebo Comparator
HRS9531 injection Placebo
干预措施: HRS9531 injection Placebo (Drug)
Treatment group H
Placebo Comparator
HRS9531 injection Placebo
干预措施: HRS9531 injection Placebo (Drug)
结局指标
主要结局
Percentage change in body weight
时间窗: Week 0, Week 24
Percentage Change from baseline in body weight after 24 weeks of treatment
次要结局
- Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment(Week 24)
- Change from baseline in body weight after 24 weeks of treatment(Week 0, Week 24)
- Change from baseline in waist circumference after 24 weeks of treatment(Week 0, Week 24)
- Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment(Week 0, Week 32)
- Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment(Week 0, Week 32)
- Number of AEs During the Trial(Week 0 to Week 56)
- Percentage change in body weight(Week 0, Week 32)
- Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment(Week 32)
- Change from baseline in body weight after 32 weeks of treatment(Week 0, Week 32)
- Change from baseline in BMI after 32 weeks of treatment(Week 0, Week 32)
- Change from baseline in BMI after 24 weeks of treatment(Week 0, Week 24)
- Change from baseline in blood pressure after 24 weeks of treatment(Week 0, Week 24)
- Change from baseline in total cholesterol after 24 weeks of treatment(Week 0, Week 24)
- Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment(Week 0, Week 24)
- Change from baseline in waist circumference after 32 weeks of treatment(Week 0, Week 32)
- Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment(Week 24)
- Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment(Week 0, Week 24)
- Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment(Week 32)
- Change from baseline in blood pressure after 32 weeks of treatment(Week 0, Week 32)
- Change from baseline in total cholesterol after 32 weeks of treatment(Week 0, Week 32)
研究者
研究点 (26)
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