Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
- Conditions
- Overweight or Obesity
- Interventions
- Drug: HRS9531 injection Placebo
- Registration Number
- NCT05881837
- Lead Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group E HRS9531 injection Placebo HRS9531 injection Placebo Treatment group A HRS9531 injection HRS9531 injection Treatment group F HRS9531 injection Placebo HRS9531 injection Placebo Treatment group G HRS9531 injection Placebo HRS9531 injection Placebo Treatment group H HRS9531 injection Placebo HRS9531 injection Placebo Treatment group B HRS9531 injection HRS9531 injection Treatment group C HRS9531 injection HRS9531 injection Treatment group D HRS9531 injection HRS9531 injection
- Primary Outcome Measures
Name Time Method Percentage change in body weight Week 0, Week 24 Percentage Change from baseline in body weight after 24 weeks of treatment
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (26)
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The people's hospital of Longhua.Shenzhen
🇨🇳Shenzhen, Guangdong, China
The First People's Hospital Of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Huadu District People's Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
The Third People's Hospital of Hubei Province
🇨🇳Wuhan, Hubei, China
Lianyungang Hospital of TCM
🇨🇳Lianyungang, Jiangsu, China
The second affiliated hospital of Anhui medical university
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Department of Endocrinology，Sencond Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
Baotou Central Hospital
🇨🇳Baotou, Inner Mongolia, China
The Central Hospital Of Huangshi
🇨🇳Huangshi, Hubei, China
North Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Second hospttoal of Shanxi medical University
🇨🇳Taiyuan, Shanxi, China
Shengjing Hospital Of China Medical University
🇨🇳Shenyang, Liaoning, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Chengdu Second People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Xi'an Medical College
🇨🇳Xian, Xian, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China