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
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.
- 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