Overweight and ObesityPhase 1NCT07559136
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
A Phase 1 study of Overweight and Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Overweight and Obesity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to Apr 2027
- Phase
- Phase 1
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects who are aged ≥12 years and <18 years at the time of signing the informed consent;
- At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
- Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
Who cannot join
- Presence of clinically significant lab results at screening visit;
- Uncontrollable hypertension;
- 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;
- Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
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- Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- Pre-adolescent participants (Tanner phase I);
- 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 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
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
- Conditions
- Overweight and 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 injection；PlaceboDrug
Drug: HRS9531 injection; low dose Drug: Placebo
HRS9531 injection；PlaceboDrug
Drug: HRS9531 injection; medium dose Drug: Placebo
HRS9531 injection；PlaceboDrug
Drug: HRS9531 injection; high dose Drug: Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS9531 injection or Placebo | Experimental | Not described Receives: Drug: HRS9531 injection；Placebo |
| Treatment group B: HRS9531 injection or Placebo | Experimental | Not described Receives: Drug: HRS9531 injection；Placebo |
| Treatment group C: HRS9531 injection or Placebo | Experimental | Not described Receives: Drug: HRS9531 injection；Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Measured: up to Week 28
Secondary outcomes (7)
Maximum concentration (Cmax) of HRS9531
Measured: up to Week 28
Trough concentration (Ctrough) of HRS9531
Measured: up to Week 28
Area under the curve from time zero to end of dosing interval (AUC0-tau)
Measured: up to Week 28
Changes from baseline in BMI
Measured: up to Week 24
Change from baseline in body weight
Measured: up to Week 24
Change from baseline in waist circumference
Measured: up to Week 24
Anti-HRS9531 antibodies (ADA)
Measured: up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start12 Jun 2026
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT07559136
- Sponsor's protocol ID
- HRS9531-111
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 28 Sep 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT07559136
- Acronym / sponsor ID
- HRS9531-111
- Conditions
- Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Apr 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.
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS9531 injection or Placebo | Experimental | Drug: HRS9531 injection；Placebo |
| Treatment group B: HRS9531 injection or Placebo | Experimental | Drug: HRS9531 injection；Placebo |
| Treatment group C: HRS9531 injection or Placebo | Experimental | Drug: HRS9531 injection；Placebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female subjects who are aged ≥12 years and <18 years at the time of signing the informed consent;
- At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
- Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
Key exclusion criteria (12 listed)
- Presence of clinically significant lab results at screening visit;
- Uncontrollable hypertension;
- 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;
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 injection；PlaceboDrug: HRS9531 injection; low dose Drug: Placebo | Drug | Treatment group A: HRS9531 injection or Placebo |
| HRS9531 injection；PlaceboDrug: HRS9531 injection; medium dose Drug: Placebo | Drug | Treatment group B: HRS9531 injection or Placebo |
| HRS9531 injection；PlaceboDrug: HRS9531 injection; high dose Drug: Placebo | Drug | Treatment group C: HRS9531 injection or Placebo |
Primary outcome
Adverse Events (AEs)
Time frame: up to Week 28
7 secondary outcomes
Maximum concentration (Cmax) of HRS9531
Time frame: up to Week 28
Trough concentration (Ctrough) of HRS9531
Time frame: up to Week 28
Area under the curve from time zero to end of dosing interval (AUC0-tau)
Time frame: up to Week 28
Changes from baseline in BMI
Time frame: up to Week 24
Change from baseline in body weight
Time frame: up to Week 24
Change from baseline in waist circumference
Time frame: up to Week 24
Anti-HRS9531 antibodies (ADA)
Time frame: up to Week 28
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 28 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Overweight and 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 3 inclusion and 12 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 28 Sep 2026. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Events (AEs) (time frame: up to Week 28). 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 28 Sep 2026.