A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects (NCT06246175) | Clinical Trial Compass
CompletedPhase 1
A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects
China32 participantsStarted 2024-02-28
Plain-language summary
The purpose of this study is to assess how fast HRS9531 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
. Age 18-65 years on the date of signing informed consent (inclusive);
. Body mass index (BMI) within the range of 19.0-40.0 kg/m2 (inclusive);
. Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
. Normal renal function: 90-129 mL/min (inclusive);
. Mild impairment: 60-89 mL/min (inclusive);
. Moderate impairment: 30-59 mL/min (inclusive);
. Severe impairment: 15-29 mL/min (inclusive);
Exclusion criteria
. Have any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy);
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to T(last) (AUC0-t)
Timeframe: Start of Treatment up to Day 29
2
Maximum Concentration of HRS9531 (Cmax)
Timeframe: Start of Treatment up to Day 29
3
Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to Infinity (AUC0-inf)
. Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
. Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
. 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;
. Allergic constitution includes severe drug allergy or history of drug allergy;
. Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
. Regularly use known drugs of abuse and/or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications;