Kidney function may change how diabetes drug works
NCT ID NCT06246175
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how the body processes HRS9531, an experimental diabetes drug, in people with different levels of kidney function. Researchers gave a single dose to 32 volunteers—some with healthy kidneys and some with mild impairment—and measured drug levels over time. The goal is to understand if kidney problems affect how the drug is absorbed and cleared, which could guide future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS9531 injection
- What this could lead to
- If successful, this study could help doctors determine the right dose of HRS9531 for people with kidney problems, making treatment safer and more effective.
- What could go wrong
- This is a very early, small study (32 people) focused on drug levels, not on treating diabetes. It won't show if HRS9531 actually works for the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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32 people
The number who actually took part.
- Started
-
Feb 2024
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chengdu Xinhua Hospital
Chengdu, Sichuan, 610000, China
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