A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects

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:
• •* Hemoglobin \<85 grams per liter (g/L);
• •* Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× the upper limit of normal (ULN) or total bilirubin (TBL) \>1.5× ULN;
• •* Serum triglyceride \> 5.64 mmol/L（500 mg/dl）;
• •* Clinical relevant elevation in serum amylase or lipase；
• •* QTcF \> 450 msec;
• •* Other abnormal lab results, as determined by the investigator.