Chronic Management of Body WeightPhase 3NCT07670884
A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
A Phase 3 study testing HRS9531 Tablet in people with Chronic Management of Body Weight, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Management of Body Weight
- What is being tested?
- HRS9531 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 675 participants
- Where
- 2 sitesChina
- Study dates
- 24 Jul 2026to 30 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18-75 years of age at the time of signing informed consent;
- At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
- Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
- Able and willing to provide a written informed consent.
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 severe hypertension;
- PHQ-9 score ≥ 15;
- Medical history or illness that affects body weight;
- History of diabetes;
- Acute or chronic hepatitis;
Show all 17Show fewer
- History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- Any organ-system malignancies developed within 5 years;
- Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;
- Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;
- Use of any medication or treatment that may have caused significant weight change within 90 days;
- History of bariatric surgery;
- Known or suspected hypersensitivity to trial product(s) or related products;
- History of alcohol and/or substance abuse or drug abuse;
- 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;
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanjing Drum Tower hospital
Nanjing, Jiangsu, 210008
Yan Bi, +86-025-83106666, biyan@nju.edu.cn
Yan Bi
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Huijuan Yuan, +86-0371-65580371, hjyuan@zzu.edu.cn
Huijuan Yuan
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.
- Conditions
- Chronic Management of Body Weight
- Being tested
- HRS9531 Tablet, HRS9531 Tablet Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 TabletDrug
HRS9531 tablet.
HRS9531 Tablet PlaceboDrug
HRS9531 tablet placebo.
| Study group | Role | What they receive |
|---|---|---|
| HRS9531 Tablet Group | Experimental | HRS9531 tablet. Receives: Drug: HRS9531 Tablet |
| HRS9531 Tablet Placebo Group | Placebo comparator | HRS9531 tablet placebo. Receives: Drug: HRS9531 Tablet Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in body weight after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Secondary outcomes (14)
Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in waist circumference after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in body weight after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in blood pressure after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in fasting plasma glucose after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in fasting serum insulin after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in glycosylated hemoglobin after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in blood lipid after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Change from baseline in blood uric acid after 52 weeks of treatment
Measured: After 52 weeks of treatment.
Number of treatment serious adverse events (SAEs) within 57 weeks
Measured: Within 57 weeks.
Number of treatment adverse events (AEs) within 57 weeks
Measured: Within 57 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start24 Jul 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Management of Body WeightStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS9531 tablets compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 675 participants (estimated)
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
- NCT07670884
- Sponsor's protocol ID
- HRS9531-T-301
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2026
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT07670884
- Acronym / sponsor ID
- HRS9531-T-301
- Conditions
- Chronic Management of Body Weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 26 Jun 2026 (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 safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HRS9531 tablets compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| HRS9531 Tablet Group | Experimental | Drug: HRS9531 TabletHRS9531 tablet. |
| HRS9531 Tablet Placebo Group | Placebo comparator | Drug: HRS9531 Tablet PlaceboHRS9531 tablet placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, 18-75 years of age at the time of signing informed consent;
- At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
- Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
- Able and willing to provide a written informed consent.
Key exclusion criteria (17 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 severe hypertension;
- PHQ-9 score ≥ 15;
- Medical history or illness that affects body 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 TabletHRS9531 tablet. | Drug | HRS9531 Tablet Group |
| HRS9531 Tablet PlaceboHRS9531 tablet placebo. | Drug | HRS9531 Tablet Placebo Group |
Primary outcome
Percentage change from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
14 secondary outcomes
Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in waist circumference after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in blood pressure after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in fasting plasma glucose after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in fasting serum insulin after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in glycosylated hemoglobin after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in blood lipid after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in blood uric acid after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Number of treatment serious adverse events (SAEs) within 57 weeks
Time frame: Within 57 weeks.
Number of treatment adverse events (AEs) within 57 weeks
Time frame: Within 57 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Management of Body Weight
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS9531 Tablet in people with Chronic Management of Body Weight, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 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 17 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danli Zhang, M.M (13162215826, danli.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in body weight after 52 weeks of treatment (time frame: After 52 weeks of treatment.). The study lists 2 primary outcomes in all. 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 13 Aug 2026.