ObesityPhase 3NCT07285902
A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity
A Phase 3 study testing HRS9531 injection and Semaglutide Injection in people with Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- HRS9531 injection and Semaglutide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 2 sitesChina
- Study dates
- 25 Dec 2025to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With my consent and has signed the informed consent form, I am willing and able to follow the requirements of the trial protocol to complete this study;
- Age ≥ 18 years old on the day of signing the informed consent, regardless of gender;
- obesity
- Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months.
- Male and female subjects of childbearing potential (including partners) who have no fertility plan and agree to take highly effective contraceptive measures within 2 months after signing the informed consent form to the last dose, and female or male subjects of childbearing potential have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test within 3 days prior to randomization and are not lactating.
Who cannot join
- Those with abnormal relevant examinations at screening;
- ECG results are abnormal and may affect the safety of the subject
- Poor blood pressure control
- The PHQ-9 score ≥ 15 points
- Presence or history of endocrine disorders that may significantly affect body weight
- History of diabetes mellitus
Show all 26Show fewer
- Those who have had any previous disease or history that affects gastric emptying, or who have undergone gastrointestinal surgery
- Previous or known history of acute or chronic pancreatitis, pancreatic injury; Patients with a history of acute cholecystitis or symptomatic/treatment-inducing gallbladder disease
- Previous or known history or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2).
- Severe infection, severe trauma, or large and medium-sized surgery within 1 month prior to screening
- History of severe cardiovascular and cerebrovascular diseases within the previous 6 months
- Malignancy of any organ system within 5 years
- Presence or suspicion of depression, bipolar disorder, suicidal tendencies, People with schizophrenia or other more serious mental illness
- Known or suspected history of alcohol and/or drug abuse or drug abuse
- Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease
- Presence of any hematologic disorder that may interfere with HbA1c detection
- Presence of autoimmune disease with planned use of systemic glucocorticoids or immunosuppressive therapy during the study
- Use of medications or treatments that may result in significant weight gain or loss within the previous 3 months
- Received, or planned to undergo bariatric surgery or endoscopic and/or medical device-based bariatric therapy during the study, etc
- Those who have a known or suspected allergy to the same or related products of the investigational drug and their excipients
- Previous discontinuation of this class for safety/tolerability reasons
- Participation in a clinical trial of any drug or medical device within 3 months prior to screening
- Those who have donated or lost ≥ 400 mL of blood within the previous 3 months, or have received blood transfusions
- Surgery is planned for the duration of the trial
- Subjects who are mentally incapacitated or have language impairment who are unable to fully understand or participate in the trial process
- Investigators and relevant staff of the research center or other persons directly involved in the implementation of the program, and their immediate family members; Employees of Hengrui Company; In the judgment of the investigator, there is any condition that affects the safety of the subject or any other interference with the evaluation of the test results
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chiness PLA General Hospital
Beijing, Beijing Municipality, 100853
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity
This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity
- Conditions
- Obesity
- Being tested
- HRS9531 injection, Semaglutide Injection
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 injectionDrug
HRS9531 injection
Semaglutide InjectionDrug
Semaglutide Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS9531 injection | Experimental | Not described Receives: Drug: HRS9531 injection |
| Treatment group B: Semaglutide Injection | Active comparator | Not described Receives: Drug: Semaglutide Injection |
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: 52 weeks
Secondary outcomes (10)
Proportion of subjects with target reduction from baseline in body weight after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in waist circumference,after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in body weight after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in body mass index (BMI) after 52 weeks of treatmentChange from baseline in blood pressure,after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in fasting plasma glucose (FPG)after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in glycosylated haemoglobin (HbA1c) after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in liver enzymes after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in fasting serum insulin after 52 weeks of treatment
Measured: 52 weeks
Change from baseline in lipid parameters after 52 weeks of treatment
Measured: 52 weeks
Number of AEs during the trial.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start25 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 572 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
- NCT07285902
- Sponsor's protocol ID
- HRS9531-308
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity
- ClinicalTrials.gov ID
- NCT07285902
- Acronym / sponsor ID
- HRS9531-308
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Dec 2025 (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 is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS9531 injection | Experimental | Drug: HRS9531 injection |
| Treatment group B: Semaglutide Injection | Active comparator | Drug: Semaglutide Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With my consent and has signed the informed consent form, I am willing and able to follow the requirements of the trial protocol to complete this study;
- Age ≥ 18 years old on the day of signing the informed consent, regardless of gender;
- obesity
- Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months.
- Male and female subjects of childbearing potential (including partners) who have no fertility plan and agree to take highly effective contraceptive measures within 2 months after signing the informed consent form to the last dose, and female or male subjects of childbearing potential have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test within 3 days prior to randomization and are not lactating.
Key exclusion criteria (26 listed)
- Those with abnormal relevant examinations at screening;
- ECG results are abnormal and may affect the safety of the subject
- Poor blood pressure control
- The PHQ-9 score ≥ 15 points
- Presence or history of endocrine disorders that may significantly affect body weight
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 | Drug | Treatment group A: HRS9531 injection |
| Semaglutide InjectionSemaglutide Injection | Drug | Treatment group B: Semaglutide Injection |
Primary outcome
Percentage change from baseline in body weight after 52 weeks of treatment
Time frame: 52 weeks
10 secondary outcomes
Proportion of subjects with target reduction from baseline in body weight after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in waist circumference,after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in body weight after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in body mass index (BMI) after 52 weeks of treatmentChange from baseline in blood pressure,after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in fasting plasma glucose (FPG)after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in glycosylated haemoglobin (HbA1c) after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in liver enzymes after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in fasting serum insulin after 52 weeks of treatment
Time frame: 52 weeks
Change from baseline in lipid parameters after 52 weeks of treatment
Time frame: 52 weeks
Number of AEs during the trial.
Time frame: 52 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 27 Feb 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.
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 injection and Semaglutide Injection in people with Obesity, 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 5 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 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. 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?
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 body weight after 52 weeks of treatment (time frame: 52 weeks). 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 27 Feb 2026.