Weight ManagementPhase 1NCT06506175
A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants
A Phase 1 study testing HRS9531 tablets in people with Weight Management and Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Type 2 Diabetes
- What is being tested?
- HRS9531 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Sep 2026
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand the trial procedures, be able and willing to provide a written informed consent.
- Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg/m^2 (both inclusive) at screening.
- Weight change does not exceed 5 kg within 3 months before screening.
- Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
- Abnormal and clinically significant blood pressure at screening.
- History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.
- Blood donation within 1 month prior to screening, or blood donation ≥ 400 mL or blood loss ≥ 400 mL within 3 months prior to screening.
- Presence of any clinically significant results in examination at screening visit.
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- Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
- Presence of - clinically significant ECG results.
- Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
- Addiction to tobacco and alcohol.
- Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period.
- In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The affiliated hospital of Qingdao University
Qingdao, Shandong, 266000
Yu Cao, Doctor, +86-0532-82911767, Caoyu1767@126.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants
The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.
- Conditions
- Weight Management, Type 2 Diabetes
- Being tested
- HRS9531 tablets
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 tabletsDrug
HRS9531 tablets.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Different fasting time and dosing conditions. Receives: Drug: HRS9531 tablets |
| Treatment group B | Experimental | Different fasting time and dosing conditions. Receives: Drug: HRS9531 tablets |
| Treatment group C | Experimental | Different fasting time and dosing conditions. Receives: Drug: HRS9531 tablets |
| Treatment group D | Experimental | Different fasting time and dosing conditions. Receives: Drug: HRS9531 tablets |
| Treatment group E | Experimental | Different fasting time and dosing conditions. Receives: Drug: HRS9531 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau
Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing
Measured: 0-24 hours after the 10th dosing.
Secondary outcomes (5)
Tmax
Time to maximum plasma concentration
Measured: First dose at day 1 and post-dose at day 10.
Cmax
The maximum plasma concentration
Measured: First dose at day 1 and post-dose at day 10.
t1/2
Terminal half-life
Measured: First dose at day 1 and post-dose at day 10.
Incidence and severity of adverse events
Measured: Screening period up to Day 45.
Anti-HRS9531 antibody
Measured: Before First dose at day 1 to Day 45.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparisons between arms with different dosing conditions, timing and food for oral HRS9531 tablets
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT06506175
- Sponsor's protocol ID
- HRS9531-T-102
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jun 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT06506175
- Acronym / sponsor ID
- HRS9531-T-102
- Conditions
- Weight Management, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jul 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 is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Comparisons between arms with different dosing conditions, timing and food for oral HRS9531 tablets
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS9531 tabletsDifferent fasting time and dosing conditions. |
| Treatment group B | Experimental | Drug: HRS9531 tabletsDifferent fasting time and dosing conditions. |
| Treatment group C | Experimental | Drug: HRS9531 tabletsDifferent fasting time and dosing conditions. |
| Treatment group D | Experimental | Drug: HRS9531 tabletsDifferent fasting time and dosing conditions. |
| Treatment group E | Experimental | Drug: HRS9531 tabletsDifferent fasting time and dosing conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to understand the trial procedures, be able and willing to provide a written informed consent.
- Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg/m^2 (both inclusive) at screening.
- Weight change does not exceed 5 kg within 3 months before screening.
- Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).
Key exclusion criteria (12 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
- Abnormal and clinically significant blood pressure at screening.
- History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.
- Blood donation within 1 month prior to screening, or blood donation ≥ 400 mL or blood loss ≥ 400 mL within 3 months 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 tabletsHRS9531 tablets. | Drug | Treatment group A, Treatment group B, Treatment group C, Treatment group D, Treatment group E |
Primary outcome
AUCtau
Time frame: 0-24 hours after the 10th dosing.
Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing
5 secondary outcomes
Tmax
Time frame: First dose at day 1 and post-dose at day 10.
Cmax
Time frame: First dose at day 1 and post-dose at day 10.
t1/2
Time frame: First dose at day 1 and post-dose at day 10.
Incidence and severity of adverse events
Time frame: Screening period up to Day 45.
Anti-HRS9531 antibody
Time frame: Before First dose at day 1 to Day 45.
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 24 Jun 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.
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 testing HRS9531 tablets in people with Weight Management and Type 2 Diabetes, 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 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: opening soon, as of the sponsor's last update on 24 Jun 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?
Contact Qianqian Yang (+86-021-61053363, qianqian.yang.qy53@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCtau (time frame: 0-24 hours after the 10th dosing.). 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 24 Jun 2026.