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RecruitingPhase 1

A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function

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

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

24

estimated

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

BMI 19-40

Primary endpoints

CmaxAUC to the last measurable concentration (AUClast)AUC extrapolated to infinity (AUCinf)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07540754
Org study IDHRS9531-110

Timeline

Milestones

Study first posted2026-04-20actual
Study start2026-05-26actual
Last update posted2026-06-01actual
Primary completion2027-01estimated (month precision)
Study completion2027-02estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. 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.

2. 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.

3. Aged 18 to 65 years (inclusive), both male and female.

4. 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).

Exclusion criteria

1. 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).

2. Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.

3. Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.

4. Drug abusers or those with a positive urine drug screening test.

5. 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.

6. Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.

7. 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).

8. History of severe hypoglycemia.

9. 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.).

10. Anyone with factors making them unsuitable to participate in this trial evaluated by the investigator.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Maximum concentration (Cmax)

Time frame:Post-dose from Day 1 to Day 29.

Cmax

concentration, descriptive

Primary/protocol endpoint/low confidence

The area under the concentration-time curve to the last measurable concentration (AUClast)

Time frame:Post-dose from Day 1 to Day 29.

concentration, descriptive

Primary/protocol endpoint

The area under the concentration-time curve extrapolated to infinity (AUCinf)

Time frame:Post-dose from Day 1 to Day 29.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum concentration (Tmax)

Time frame:Post-dose from Day 1 to Day 29.

Tmax

descriptive

Secondary/protocol endpoint

Half-life (t1/2)

Time frame:Post-dose from Day 1 to Day 29.

Half-life

descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F)

Time frame:Post-dose from Day 1 to Day 29.

descriptive

Secondary/protocol endpoint

Apparent volume of distribution (Vz/F)

Time frame:Post-dose from Day 1 to Day 29.

descriptive

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:Day 1 to Day 36.

Treatment-emergent AEs (any)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.