Overweight or ObesityPhase 3NCT06396429
To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese
A Phase 3 study testing HRS9531 injection in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 567 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2024to 7 Jul 2025
- Phase
- Phase 3
- 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 years and older
- 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 years of age at the time of signing informed consent.
- At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
- 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.
- Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.
Who cannot join
- Presence of clinically significant lab results 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;
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- 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、 in-situ cancer of the cervix and in-situ cancer of the prostate;
- Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
- Known or suspected history of alcohol and/or substance abuse or drug abuse;
- History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.
- Have received or plan to have an organ or bone marrow transplant during the study.
- The presence of any blood disorders that may interfere with HbA1c testing.
- Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.
- Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;
- Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
- Surgery is planned during the tria;
- Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；
- In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of the test results.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.
- Conditions
- Overweight or Obesity
- Being tested
- 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; low dose
HRS9531 injectionDrug
HRS9531 injection; medium dose
HRS9531 injectionDrug
HRS9531 injection, high dose
PlaceboDrug
blank preparation, participants received matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS9531 injection | Experimental | Not described Receives: Drug: HRS9531 injection |
| Treatment group B: HRS9531 injection | Experimental | Not described Receives: Drug: HRS9531 injection |
| Treatment group C: HRS9531 injection | Experimental | Not described Receives: Drug: HRS9531 injection |
| Placebo injection | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in weight after 48 weeks of treatment
Measured: Baseline, Week 48
Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment
Measured: Week 48
Secondary outcomes (16)
Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment
Measured: Week 48
Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment
Measured: Week 48
Change from baseline in waist circumference after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in weight after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in BMI after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in systolic blood pressure after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in diastolic blood pressure after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in Total Cholesterol after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in Triglycerides after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment
Measured: Baseline, Week 48
Change from baseline in fasting serum insulin after 48 weeks of treatment
Measured: Baseline, Week 48
Change in scores of SF-36 V2 from baseline after 48 weeks of treatment
Measured: Baseline, Week 48
Number of AEs during the trial
Measured: week 0 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start13 May 2024
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 567 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
- NCT06396429
- Sponsor's protocol ID
- HRS9531-301
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2024
- Last updated
- 11 Jul 2025
- 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 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06396429
- Acronym / sponsor ID
- HRS9531-301
- Conditions
- Overweight or Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 2 May 2024 (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.
The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS9531 injection | Experimental | Drug: HRS9531 injection |
| Treatment group B: HRS9531 injection | Experimental | Drug: HRS9531 injection |
| Treatment group C: HRS9531 injection | Experimental | Drug: HRS9531 injection |
| Placebo injection | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide a written informed consent.
- Male or female subjects, ≥18 years of age at the time of signing informed consent.
- At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
- 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.
- Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.
Key exclusion criteria (21 listed)
- Presence of clinically significant lab results 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; low dose | Drug | Treatment group A: HRS9531 injection |
| HRS9531 injectionHRS9531 injection; medium dose | Drug | Treatment group B: HRS9531 injection |
| HRS9531 injectionHRS9531 injection, high dose | Drug | Treatment group C: HRS9531 injection |
| Placeboblank preparation, participants received matching placebo. | Drug | Placebo injection |
Primary outcome
Percentage change from baseline in weight after 48 weeks of treatment
Time frame: Baseline, Week 48
Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment
Time frame: Week 48
16 secondary outcomes
Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment
Time frame: Week 48
Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment
Time frame: Week 48
Change from baseline in waist circumference after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in weight after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in BMI after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in systolic blood pressure after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in diastolic blood pressure after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in Total Cholesterol after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in Triglycerides after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment
Time frame: Baseline, Week 48
Change from baseline in fasting serum insulin after 48 weeks of treatment
Time frame: Baseline, Week 48
Change in scores of SF-36 V2 from baseline after 48 weeks of treatment
Time frame: Baseline, Week 48
Number of AEs during the trial
Time frame: week 0 to week 52
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 11 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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 injection in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site 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 5 inclusion and 21 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 from baseline in weight after 48 weeks of treatment (time frame: Baseline, Week 48). 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 11 Jul 2025.