Overweight or ObesityPhase 2NCT05881837
A Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
A Phase 2 study testing HRS9531 injection in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 25 sites in China.
Trial summary
This study aims 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- HRS9531 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 25 sitesChina
- Study dates
- 13 Jun 2023to 13 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Baotou Central Hospital
Baotou, Inner Mongolia, 014040
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The Second Hospital of Jilin University
Changchun, Jilin, 130022
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, 510800
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
The Central Hospital Of Huangshi
Huangshi, Hubei, 435000
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Lianyungang Hospital of TCM
Lianyungang, Jiangsu, 222001
The First People's Hospital Of Lianyungang
Lianyungang, Jiangsu, 222002
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, 471000
Sencond Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110004
The People's Hospital of Longhua. Shenzhen
Shenzhen, Guangdong, 518110
Second Hospttoal of Shanxi Medical University
Taiyuan, Shanxi, 030000
The Third People's Hospital of Hubei Province
Wuhan, Hubei, 430000
The First Affiliated Hospital of Xi'an Medical College
Xian, Shanxi, 710000
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 222004
North Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
About this study
Official title: 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
This study aims 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.
- Conditions
- Overweight or Obesity
- Being tested
- HRS9531 injection, HRS9531 injection Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 injectionDrug
HRS9531 injection: dose level 1 for 32 weeks; level 2 for 20 weeks
HRS9531 injectionDrug
HRS9531 injection: dose level 2
HRS9531 injectionDrug
HRS9531 injection: dose level 3
HRS9531 injectionDrug
HRS9531 injection: dose level 4
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks; HRS9531 injection level 2 for 20 weeks
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks; HRS9531 injection level 2 for 20 weeks
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks; HRS9531 injection level 2 for 20 weeks
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks; HRS9531 injection level 2 for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | HRS9531 injection Receives: Drug: HRS9531 injection |
| Treatment group B | Experimental | HRS9531 injection Receives: Drug: HRS9531 injection |
| Treatment group C | Experimental | HRS9531 injection Receives: Drug: HRS9531 injection |
| Treatment group D | Experimental | HRS9531 injection Receives: Drug: HRS9531 injection |
| Treatment group E | Placebo comparator | HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo |
| Treatment group F | Placebo comparator | HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo |
| Treatment group G | Placebo comparator | HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo |
| Treatment group H | Placebo comparator | HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight
Percentage Change from baseline in body weight after 24 weeks of treatment
Measured: 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
Measured: Week 24
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Measured: Week 24
Change from baseline in body weight after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in waist circumference after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in BMI after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in blood pressure after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in total cholesterol after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Measured: Week 0, Week 24
Number of AEs During the Trial
Measured: Week 0 to Week 56
Percentage change in body weight
Measured: Week 0, Week 32
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment
Measured: Week 32
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment
Measured: Week 32
Change from baseline in body weight after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in waist circumference after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in BMI after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in blood pressure after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in total cholesterol after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment
Measured: Week 0, Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start13 Jun 2023
- Primary completion13 Oct 2024
- Study completion13 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881837
- Sponsor's protocol ID
- HRS9531-201
- Status last verified
- Oct 2026
- First submitted
- 17 May 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05881837
- Acronym / sponsor ID
- HRS9531-201
- Conditions
- Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 13 Oct 2024 (actual)
- Study completion
- 13 Oct 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS9531 injectionHRS9531 injection |
| Treatment group B | Experimental | Drug: HRS9531 injectionHRS9531 injection |
| Treatment group C | Experimental | Drug: HRS9531 injectionHRS9531 injection |
| Treatment group D | Experimental | Drug: HRS9531 injectionHRS9531 injection |
| Treatment group E | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo |
| Treatment group F | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo |
| Treatment group G | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo |
| Treatment group H | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS9531 injectionHRS9531 injection: dose level 1 for 32 weeks; level 2 for 20 weeks | Drug | Treatment group A |
| HRS9531 injectionHRS9531 injection: dose level 2 | Drug | Treatment group B |
| HRS9531 injectionHRS9531 injection: dose level 3 | Drug | Treatment group C |
| HRS9531 injectionHRS9531 injection: dose level 4 | Drug | Treatment group D |
| HRS9531 injection PlaceboPlacebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks; HRS9531 injection level 2 for 20 weeks | Drug | Treatment group E |
| HRS9531 injection PlaceboPlacebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks; HRS9531 injection level 2 for 20 weeks | Drug | Treatment group F |
| HRS9531 injection PlaceboPlacebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks; HRS9531 injection level 2 for 20 weeks | Drug | Treatment group G |
| HRS9531 injection PlaceboPlacebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks; HRS9531 injection level 2 for 20 weeks | Drug | Treatment group H |
Primary outcome
Percentage change in body weight
Time frame: Week 0, Week 24
Percentage Change from baseline in body weight after 24 weeks of treatment
20 secondary outcomes
Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Time frame: Week 24
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Time frame: Week 24
Change from baseline in body weight after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in waist circumference after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in BMI after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in blood pressure after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in total cholesterol after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Time frame: Week 0, Week 24
Number of AEs During the Trial
Time frame: Week 0 to Week 56
Percentage change in body weight
Time frame: Week 0, Week 32
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment
Time frame: Week 32
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment
Time frame: Week 32
Change from baseline in body weight after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in waist circumference after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in BMI after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in blood pressure after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in total cholesterol after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment
Time frame: Week 0, Week 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight or Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS9531 injection in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 25 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight (time frame: Week 0, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.