Overweight or ObesityPhase 2NCT06054698
Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects
A Phase 2 study testing HRS9531 injection in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 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
- 61 participants
- Where
- 4 sitesChina
- Study dates
- 16 Oct 2023to 9 Sep 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.
- 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit.
- 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.
- poor-controlled hypertension.
- PHQ-9 score ≥15.
- Medical history of illness that affects 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.
- Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ.
- Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness.
- History of alcohol , medication or drug abuse within 1 year prior to screening.
- Use of any medication or treatment that may cause significant weight change within 3 months.
- History of bariatric surgery.
- Subjects participating in QT/QTc studies need to comply with relevant examinations.
- Known or suspected hypersensitivity to trial product(s) or related products.
- Participation in other clinical trials within 3 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.
- In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Zhejiang Hospital
Hangzhou, Zhejiang, 310007
Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Jinan Central Hospital
Jinan, Shandong, 250013
The Affiliated Hospital of Xuzhou Medicine University
Xuzhou, Jiangsu, 221000
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Overweight or Obese Subjects
To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 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 , QW，36 weeks
HRS9531 injection PlaceboDrug
HRS9531 injection Placebo，QW，36 weeks
| Study group | Role | What they receive |
|---|---|---|
| HRS9531 injection | Experimental | Not described Receives: Drug: HRS9531 injection |
| HRS9531 injection Placebo | Placebo comparator | Not described 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
Measured: Week 0, Week 36
Secondary outcomes (11)
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment
Measured: Week 36
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment
Measured: Week 36
Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment
Measured: Week 36
Change from baseline in body weight after 36 weeks of treatment
Measured: Week 0, Week 36
Change from baseline in waist circumference after 36 weeks of treatment
Measured: Week 0, Week 36
Change from baseline in BMI after 36 weeks of treatment
Measured: Week 0, Week 36
Change from baseline in blood pressure after 36 weeks of treatment
Measured: Week 0, Week 36
Change from baseline in total cholesterol after 36 weeks of treatment
Measured: Week 0, Week 36
Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment
Measured: Week 0, Week36
Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment
Measured: Week 0, Week 36
Number of AEs During the Trial
Measured: Week 0 to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start16 Oct 2023
- Primary completion9 Sep 2024
- Study completion9 Sep 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 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
- NCT06054698
- Sponsor's protocol ID
- HRS9531-203
- Status last verified
- May 2026
- First submitted
- 19 Sep 2023
- Last updated
- 22 May 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 May 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 Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT06054698
- Acronym / sponsor ID
- HRS9531-203
- Conditions
- Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 26 Sep 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.
To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS9531 injection | Experimental | Drug: HRS9531 injection |
| HRS9531 injection Placebo | Placebo comparator | Drug: HRS9531 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.
- 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit.
- 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 (21 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.
- poor-controlled hypertension.
- PHQ-9 score ≥15.
- Medical history of illness that affects 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 , QW，36 weeks | Drug | HRS9531 injection |
| HRS9531 injection PlaceboHRS9531 injection Placebo，QW，36 weeks | Drug | HRS9531 injection Placebo |
Primary outcome
Percentage change in body weight
Time frame: Week 0, Week 36
11 secondary outcomes
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment
Time frame: Week 36
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment
Time frame: Week 36
Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment
Time frame: Week 36
Change from baseline in body weight after 36 weeks of treatment
Time frame: Week 0, Week 36
Change from baseline in waist circumference after 36 weeks of treatment
Time frame: Week 0, Week 36
Change from baseline in BMI after 36 weeks of treatment
Time frame: Week 0, Week 36
Change from baseline in blood pressure after 36 weeks of treatment
Time frame: Week 0, Week 36
Change from baseline in total cholesterol after 36 weeks of treatment
Time frame: Week 0, Week 36
Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment
Time frame: Week 0, Week36
Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment
Time frame: Week 0, Week 36
Number of AEs During the Trial
Time frame: Week 0 to Week 36
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 May 2026.
- 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.
4 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 4 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 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 36). 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 May 2026.