Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
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
1 other identifier
interventional
249
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2023
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedStudy Start
First participant enrolled
June 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2024
CompletedApril 30, 2025
April 1, 2025
1.3 years
May 17, 2023
April 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage change in body weight
Percentage Change from baseline in body weight after 24 weeks of treatment
Week 0, Week 24
Secondary Outcomes (20)
Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Week 24
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 BMI after 24 weeks of treatment
Week 0, Week 24
- +15 more secondary outcomes
Study Arms (8)
Treatment group A
EXPERIMENTALHRS9531 injection
Treatment group B
EXPERIMENTALHRS9531 injection
Treatment group C
EXPERIMENTALHRS9531 injection
Treatment group D
EXPERIMENTALHRS9531 injection
Treatment group E
PLACEBO COMPARATORHRS9531 injection Placebo
Treatment group F
PLACEBO COMPARATORHRS9531 injection Placebo
Treatment group G
PLACEBO COMPARATORHRS9531 injection Placebo
Treatment group H
PLACEBO COMPARATORHRS9531 injection Placebo
Interventions
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
The second affiliated hospital of Anhui medical university
Hefei, Anhui, 230601, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, 510800, China
The people's hospital of Longhua.Shenzhen
Shenzhen, Guangdong, 518110, China
Department of Endocrinology，Sencond Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000, China
The Central Hospital Of Huangshi
Huangshi, Hubei, 435000, China
The Third People's Hospital of Hubei Province
Wuhan, Hubei, 430000, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014040, China
Lianyungang Hospital of TCM
Lianyungang, Jiangsu, 222001, China
The First People's Hospital Of Lianyungang
Lianyungang, Jiangsu, 222002, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
The Second Hospital of Jilin University
Changchun, Jilin, 130022, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110004, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 20032, China
Second hospttoal of Shanxi medical University
Taiyuan, Shanxi, 030000, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000, China
The First Affiliated Hospital of Xi'an Medical College
Xi'an, Xian, 710000, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2023
First Posted
May 31, 2023
Study Start
June 13, 2023
Primary Completion
October 13, 2024
Study Completion
October 13, 2024
Last Updated
April 30, 2025
Record last verified: 2025-04