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 range18 Years – 65 Years

SexALL

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;
✕. 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;

What they're measuring

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

Maximum Concentration of HRS9531 (Cmax)

Timeframe: Start of Treatment up to Day 29

Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to Infinity (AUC0-inf)

Timeframe: Start of Treatment up to Day 29

Trial details

NCT IDNCT06246175

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-02

View on ClinicalTrials.gov More Type 2 Diabetes trials

Who can participate

Age range18 Years – 65 Years

SexALL

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;
✕. 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;

What they're measuring

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

Maximum Concentration of HRS9531 (Cmax)

Timeframe: Start of Treatment up to Day 29

Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to Infinity (AUC0-inf)

Timeframe: Start of Treatment up to Day 29