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

NCT06246175 | Completed Phase 1

• 1 other identifier: HRS9531-105
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to T(last) (AUC0-t)

  Start of Treatment up to Day 29

• Maximum Concentration of HRS9531 (Cmax)

  Start of Treatment up to Day 29

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

  Start of Treatment up to Day 29

Secondary Outcomes (5)

• Time to maximum concentration (Tmax)

  Start of Treatment up to Day 29

• Apparent terminal half-life (t1/2)

  Start of Treatment up to Day 29

• Apparent clearance (CL/F)

  Start of Treatment up to Day 29

• Apparent volume of distribution (Vz/F)

  Start of Treatment up to Day 29

• Incidence and severity of adverse events

  Screening period up to Day 29

Study Arms (4)

A group (Healthy Control)

EXPERIMENTAL

Drug: HRS9531

B group (Mild Renal Impairment)

EXPERIMENTAL

Drug: HRS9531

C group (Moderate Renal Impairment)

EXPERIMENTAL

Drug: HRS9531

D group (Severe Renal Impairment)

EXPERIMENTAL

Drug: HRS9531

Interventions

HRS9531 DRUG

Receive a single dose of HRS9531 injection

A group (Healthy Control); B group (Mild Renal Impairment); C group (Moderate Renal Impairment); D group (Severe Renal Impairment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;
• Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
• Diagnosed as stable, chronic renal disease for at least 3 months.

You may not qualify if:

• 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;
• 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);
• 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;
• Breast-feeding women;
• 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;
• History of Vasovagal Syncope; Do not have venous access sufficient to allow blood sampling as per the protocol；
• The need to follow a special diet and unable to follow the diet requirement of protocol;
• The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a single-dose, parallel design trial.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 28, 2024
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)