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A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects
A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of HRS9531injection in Healthy Subjects and Subjects With Impaired Renal Function
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
32
actual
Study population
Healthy volunteers, Renal impairment
Key I/E criteria
•BMI 19-40•Healthy volunteers
Primary endpoints
•AUC of HRS9531•Cmax of HRS9531(Cmax)
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
2. Age 18-65 years on the date of signing informed consent (inclusive);
3. Body mass index (BMI) within the range of 19.0-40.0 kg/m2 (inclusive);
4. Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
1. Normal renal function: 90-129 mL/min (inclusive);
2. Mild impairment: 60-89 mL/min (inclusive);
3. Moderate impairment: 30-59 mL/min (inclusive);
4. Severe impairment: 15-29 mL/min (inclusive);
5. Females of childbearing potential should have negative baseline blood pregnancy test, and must use highly effective contraception from signing the informed consent form to 2 months after the last dose of trial drug; Male subjects must agree to either remain abstinent or use highly effective contraceptive measures during the trial and 2 months after last dose of the trial drug, or have been surgically sterilized;
6. Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
7. Diagnosed as stable, chronic renal disease for at least 3 months.
Exclusion criteria
1. Have any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy);
2. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; Have a history or presence of pancreatitis;
3. Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
4. Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
5. Blood donation history or blood loss ≥400 mL within 3 month or ≥200 mL within 1 month before screening, or received blood transfusion within 3 months;
6. Allergic constitution includes severe drug allergy or history of drug allergy;
7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
8. Regularly use known drugs of abuse and/or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications;
9. Have an average weekly alcohol intake that exceeds 14 units per week or average daily cigarettes consumption exceeds 5 per day, and are unwilling to stop alcohol or cigarettes consumption 24 hours prior to dosing until discharge from the study or completion of all study procedures (1 unit =12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits);
10. History use of GLP-1R(glucagon-like peptide-1 receptor) agonist, GLP-1R/GCGR(glucagon receptor)agonist, GIPR(glucose-dependent insulinotropic polypeptide receptor/GLP-1R agonist or GIPR/GLP-1R/GCGR agonist within 2 months prior to screening;
11. Breast-feeding women;
12. The use of alcohol- or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1), unless deemed acceptable by the investigator;
13. History of Vasovagal Syncope; Do not have venous access sufficient to allow blood sampling as per the protocol;
14. The need to follow a special diet and unable to follow the diet requirement of protocol;
15. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study
16. Healthy Participants:
1. Systolic blood pressure <90 mmHg or ≥140 mmHg; Diastolic blood pressure <50 mmHg 或≥90 mmHg; Heart Rate < 50 beats/min or >100 beats/min;
2. Have a significant history or presence of cardiovascular (eg, myocardial infarction, cerebrovascular accident, etc. within the past 6 months), respiratory, hepatic, renal, GI, endocrine (except T2DM), haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data;
3. Use of medications determined to be unsuitable by the investigator (including over-the-counter medication, prescription medication and herbal preparations) within the 14 days prior to screening;
4. Have clinical laboratory test results outside normal reference range for the population or investigator site and judged to be clinically significant by the investigator;
17. Participants with Renal Impairment:
1. Systolic blood pressure <90 mmHg or≥160 mmHg; Diastolic blood pressure <50 mmHg 或 ≥100 mmHg; Heart Rate < 50 beats/min or >100 beats/min;
2. Have a significant history or presence of cardiovascular (eg, myocardial infarction, cerebrovascular accident, decompensated heart failure (NYHA classification III or IV), etc. within the past 6 months), respiratory, hepatic, renal (obstructive urinary tract disease, except CKD), GI, endocrine (except T2DM), haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data;
3. History of Kidney Transplant;
4. Subjects started new over-the-counter or prescription medications (eg, antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions or on their treatment regimen for less than 1 month;
5. Have following clinically relevant abnormal laboratory test results:
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 endpointsArea Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to T(last) (AUC0-t)
Time frame:Start of Treatment up to Day 29
AUC₀–∞
concentration, descriptive
Maximum Concentration of HRS9531 (Cmax)
Time frame:Start of Treatment up to Day 29
Cmax
concentration, descriptive
Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to Infinity (AUC0-inf)
Time frame:Start of Treatment up to Day 29
AUC₀–∞
concentration, descriptive
Time to maximum concentration (Tmax)
Time frame:Start of Treatment up to Day 29
Tmax
descriptive
Apparent terminal half-life (t1/2)
Time frame:Start of Treatment up to Day 29
Half-life
descriptive
Apparent clearance (CL/F)
Time frame:Start of Treatment up to Day 29
descriptive
Apparent volume of distribution (Vz/F)
Time frame:Start of Treatment up to Day 29
descriptive
Incidence and severity of adverse events
Time frame:Screening period up to Day 29
Treatment-emergent AEs (any)
descriptive, event
Provenance
Sources
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.