RecruitingPhase 1NCT06246175

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

A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of HRS9531injection in Healthy Subjects and Subjects With Impaired Renal Function


Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Enrollment

32 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a drug called HRS9531 — which belongs to a class of diabetes and obesity medications called GLP-1/GIP receptor agonists — behaves in the body (how it is absorbed, broken down, and eliminated) in people with varying degrees of kidney function. This pharmacokinetics study is an important safety step before the drug can be more widely tested. **You may be eligible if...** - You are between 18 and 65 years old - Your body mass index (BMI) is between 19 and 40 - You fall into one of five kidney function categories: normal, mild impairment, moderate impairment, severe impairment, or end-stage kidney failure (on dialysis) - Women who could become pregnant must use effective contraception and test negative for pregnancy **You may NOT be eligible if...** - You have a history of serious allergic reactions to similar GLP-1 medications - You have personal or family history of thyroid cancer (specifically medullary thyroid carcinoma) or a rare endocrine tumor syndrome (MEN2) - You have uncontrolled diabetes or other serious metabolic conditions - You are pregnant, breastfeeding, or planning pregnancy during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS9531

Receive a single dose of HRS9531 injection


Locations(1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China

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NCT06246175


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