Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
NCT ID: NCT05881837
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
249 participants
INTERVENTIONAL
2023-06-13
2024-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment group A
HRS9531 injection
HRS9531 injection
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Treatment group B
HRS9531 injection
HRS9531 injection
HRS9531 injection: dose level 2
Treatment group C
HRS9531 injection
HRS9531 injection
HRS9531 injection: dose level 3
Treatment group D
HRS9531 injection
HRS9531 injection
HRS9531 injection: dose level 4
Treatment group E
HRS9531 injection Placebo
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Treatment group F
HRS9531 injection Placebo
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Treatment group G
HRS9531 injection Placebo
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Treatment group H
HRS9531 injection Placebo
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Interventions
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HRS9531 injection
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
HRS9531 injection
HRS9531 injection: dose level 2
HRS9531 injection
HRS9531 injection: dose level 3
HRS9531 injection
HRS9531 injection: dose level 4
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Eligibility Criteria
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Inclusion Criteria
2. Male or female subjects, 18-65 years of age at the time of signing informed consent;
3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
4. 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.
Exclusion Criteria
2. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects your weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. 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;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. 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;
15. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
16. Surgery is planned during the trial;
17. Mentally incapacitated or speech-impaired;
18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
18 Years
65 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The second affiliated hospital of Anhui medical university
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, China
The people's hospital of Longhua.Shenzhen
Shenzhen, Guangdong, 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
The Central Hospital Of Huangshi
Huangshi, Hubei, China
The Third People's Hospital of Hubei Province
Wuhan, Hubei, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Lianyungang Hospital of TCM
Lianyungang, Jiangsu, China
The First People's Hospital Of Lianyungang
Lianyungang, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Second hospttoal of Shanxi medical University
Taiyuan, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Xi'an Medical College
Xi'an, Xian, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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HRS9531-201
Identifier Type: -
Identifier Source: org_study_id
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