Diabetes MellitusPhase 1NCT07540754
A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
A Phase 1 study testing HRS9531 Injection in people with Diabetes Mellitus and Weight Loss, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Weight Loss
- What is being tested?
- HRS9531 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to Feb 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must fully understand and voluntarily sign a written informed consent form before the trial, demonstrating comprehension of the trial content, procedures, and potential adverse reactions; they must also be willing and able to comply with the protocol requirements to complete the study.
- Female participants of childbearing potential must have a negative baseline serum pregnancy test, must not be lactating, and must agree to use contraceptive measures and refrain from egg donation from the time of signing the informed consent form until 2 months after the last dose of the study drug; male participants with partners of childbearing potential must agree to use contraceptive measures and refrain from sperm donation from the time of signing the informed consent form until 2 months after the last dose of the study drug.
- Aged 18 to 65 years (inclusive), both male and female.
- Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) is within the range of 19.0 to 40.0 kg/m² (inclusive).
Who cannot join
- Participation in any clinical trial of a drug or medical device within 3 months prior to dosing, or currently within the follow-up period of a clinical study or within 5 half-lives of the investigational drug (whichever is longer).
- Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.
- Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.
- Drug abusers or those with a positive urine drug screening test.
- Blood loss or blood donation ≥400 mL within 3 months prior to dosing, or blood loss or blood donation ≥ 200 mL within 1 month prior to dosing, or receipt of a blood transfusion within 3 months prior to dosing.
- Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.
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- Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia).
- History of severe hypoglycemia.
- Previous significant gastric emptying abnormalities or factors affecting gastric emptying (e.g., history of gastric bypass surgery, pyloric stenosis), or severe gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, etc.), or have undergone gastrointestinal surgery (excluding surgeries with no significant impact on gastrointestinal motility, such as removal of gastrointestinal polyps, appendectomy, hemorrhoidectomy, etc.).
- Anyone with factors making them unsuitable to participate in this trial evaluated by the investigator.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zujiang Yu, +86-0371-6691694, johnyuem@zzu.edu.cn
Xin Tian, +86-13903830361, tianx@zzu.cn
About this study
Official title: A Multi-center, Single-dose, Parallel-group, Open-label Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.
- Conditions
- Diabetes Mellitus, Weight Loss
- Being tested
- HRS9531 Injection
- Medical subject headings
- Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 InjectionDrug
HRS9531 injection, specified dose on the specified day.
| Study group | Role | What they receive |
|---|---|---|
| Group of Participants with mild hepatic impairment | Experimental | Participants with mild hepatic impairment. Receives: Drug: HRS9531 Injection |
| Group of Participants with moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment. Receives: Drug: HRS9531 Injection |
| Group of Participants with normal hepatic function | Experimental | Participants with normal hepatic function. Receives: Drug: HRS9531 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
HRS9531 key PK parameter.
Measured: Post-dose from Day 1 to Day 29.
The area under the concentration-time curve to the last measurable concentration (AUClast)
HRS9531 key PK parameter.
Measured: Post-dose from Day 1 to Day 29.
The area under the concentration-time curve extrapolated to infinity (AUCinf)
HRS9531 key PK parameter.
Measured: Post-dose from Day 1 to Day 29.
Secondary outcomes (5)
Time to maximum concentration (Tmax)
HRS9531 other PK parameter.
Measured: Post-dose from Day 1 to Day 29.
Half-life (t1/2)
HRS9531 other PK parameter.
Measured: Post-dose from Day 1 to Day 29.
Apparent clearance (CL/F)
HRS9531 other PK parameter.
Measured: Post-dose from Day 1 to Day 29.
Apparent volume of distribution (Vz/F)
HRS9531 other PK parameter.
Measured: Post-dose from Day 1 to Day 29.
Adverse events (AEs)
Safety and tolerability measure.
Measured: Day 1 to Day 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start26 May 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study aims to compare the pharmacokinetics of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function.
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT07540754
- Sponsor's protocol ID
- HRS9531-110
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 1 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-dose, Parallel-group, Open-label Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07540754
- Acronym / sponsor ID
- HRS9531-110
- Conditions
- Diabetes Mellitus, Weight Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 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.
This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study aims to compare the pharmacokinetics of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function.
| Arm | Type | Receives |
|---|---|---|
| Group of Participants with mild hepatic impairment | Experimental | Drug: HRS9531 InjectionParticipants with mild hepatic impairment. |
| Group of Participants with moderate hepatic impairment | Experimental | Drug: HRS9531 InjectionParticipants with moderate hepatic impairment. |
| Group of Participants with normal hepatic function | Experimental | Drug: HRS9531 InjectionParticipants with normal hepatic function. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must fully understand and voluntarily sign a written informed consent form before the trial, demonstrating comprehension of the trial content, procedures, and potential adverse reactions; they must also be willing and able to comply with the protocol requirements to complete the study.
- Female participants of childbearing potential must have a negative baseline serum pregnancy test, must not be lactating, and must agree to use contraceptive measures and refrain from egg donation from the time of signing the informed consent form until 2 months after the last dose of the study drug; male participants with partners of childbearing potential must agree to use contraceptive measures and refrain from sperm donation from the time of signing the informed consent form until 2 months after the last dose of the study drug.
- Aged 18 to 65 years (inclusive), both male and female.
- Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) is within the range of 19.0 to 40.0 kg/m² (inclusive).
Key exclusion criteria (10 listed)
- Participation in any clinical trial of a drug or medical device within 3 months prior to dosing, or currently within the follow-up period of a clinical study or within 5 half-lives of the investigational drug (whichever is longer).
- Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.
- Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.
- Drug abusers or those with a positive urine drug screening test.
- Blood loss or blood donation ≥400 mL within 3 months prior to dosing, or blood loss or blood donation ≥ 200 mL within 1 month prior to dosing, or receipt of a blood transfusion within 3 months prior to dosing.
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, specified dose on the specified day. | Drug | Group of Participants with mild hepatic impairment, Group of Participants with moderate hepatic impairment, Group of Participants with normal hepatic function |
Primary outcome
Maximum concentration (Cmax)
Time frame: Post-dose from Day 1 to Day 29.
HRS9531 key PK parameter.
The area under the concentration-time curve to the last measurable concentration (AUClast)
Time frame: Post-dose from Day 1 to Day 29.
HRS9531 key PK parameter.
The area under the concentration-time curve extrapolated to infinity (AUCinf)
Time frame: Post-dose from Day 1 to Day 29.
HRS9531 key PK parameter.
5 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Post-dose from Day 1 to Day 29.
Half-life (t1/2)
Time frame: Post-dose from Day 1 to Day 29.
Apparent clearance (CL/F)
Time frame: Post-dose from Day 1 to Day 29.
Apparent volume of distribution (Vz/F)
Time frame: Post-dose from Day 1 to Day 29.
Adverse events (AEs)
Time frame: Day 1 to Day 36.
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 1 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 Injection in people with Diabetes Mellitus and Weight Loss, 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 1 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 Yanyan Zhang (+86-0518-81220121, yanyan.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) (time frame: Post-dose from Day 1 to Day 29.). The study lists 3 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 1 Jun 2026.