NCT06054698已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Overweight or Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Percentage change in body weight
研究概览
简要总结
To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 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.
- •28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit.
- •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.
- •poor-controlled hypertension.
- •PHQ-9 score ≥
- •Medical history of illness that affects 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.
- •Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ.
- •Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness.
- •History of alcohol , medication or drug abuse within 1 year prior to screening.
- •Use of any medication or treatment that may cause significant weight change within 3 months.
- •History of bariatric surgery.
- •Subjects participating in QT/QTc studies need to comply with relevant examinations.
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Participation in other clinical trials within 3 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.
- •In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.
研究组 & 干预措施
HRS9531 injection Placebo
Placebo Comparator
干预措施: HRS9531 injection Placebo (Drug)
HRS9531 injection
Experimental
干预措施: HRS9531 injection (Drug)
结局指标
主要结局
Percentage change in body weight
时间窗: Week 0, Week 36
次要结局
- Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment(Week 36)
- Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment(Week 36)
- Change from baseline in body weight after 36 weeks of treatment(Week 0, Week 36)
- Change from baseline in waist circumference after 36 weeks of treatment(Week 0, Week 36)
- Change from baseline in total cholesterol after 36 weeks of treatment(Week 0, Week 36)
- Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment(Week 0, Week36)
- Number of AEs During the Trial(Week 0 to Week 36)
- Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment(Week 36)
- Change from baseline in BMI after 36 weeks of treatment(Week 0, Week 36)
- Change from baseline in blood pressure after 36 weeks of treatment(Week 0, Week 36)
- Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment(Week 0, Week 36)
研究者
研究点 (4)
Loading locations...
相似试验
尚未招募
2 期
A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep ApneaWeight ManagementNCT06565871Fujian Shengdi Pharmaceutical Co., Ltd.108
已完成
2 期
Efficacy and Safety of HRS9531 Injection in Obese Subjects Without DiabetesOverweight or ObesityNCT05881837Fujian Shengdi Pharmaceutical Co., Ltd.249
已完成
2 期
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes SubjectsType 2 DiabetesNCT05966272Fujian Shengdi Pharmaceutical Co., Ltd.199
已完成
3 期
the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise AloneDiabetes Mellitus, Type 2NCT06650007Fujian Shengdi Pharmaceutical Co., Ltd.218
Unknown
2 期
The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without DiabetesObesityNCT04799327Jiangsu HengRui Medicine Co., Ltd.254