RecruitingPhase 1NCT07385547

Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency

A Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of GL0034

Sponsor

Sun Pharmaceutical Industries Limited

Enrollment

40 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

Type II Diabetes Mellitus

Summary

This is an open-label, single-dose, Phase 1 clinical study designed to evaluate the effect of renal impairment on the pharmacokinetics (PK) of GL0034, a long-acting GLP-1 receptor agonist. Approximately 40 adult participants will be enrolled across four groups: normal renal function, moderate renal impairment, severe renal impairment without dialysis, and severe renal impairment with dialysis. Each participant will receive a single subcutaneous dose of GL0034. Blood samples will be collected for PK analysis. Secondary objectives include assessing safety and tolerability. The study will help determine whether renal impairment affects GL0034 exposure and inform dosing recommendations for patients with compromised renal function.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how kidney function affects how the body processes a specific drug. People with different levels of kidney function — from normal to severely impaired, including those on dialysis — will be enrolled to understand whether the drug dose needs to be adjusted based on kidney health. **You may be eligible if...** - You are between 18 and 80 years old - You have a BMI between 18 and 42 kg/m² - You fall into one of these kidney function categories: normal kidneys, moderately reduced kidney function, severely reduced kidney function (not on dialysis), or on regular hemodialysis - You are willing and able to provide informed consent and follow study requirements **You may NOT be eligible if...** - Your kidney function falls outside the defined study categories - Your BMI is outside the 18–42 range - You are pregnant, breastfeeding, or unwilling to use effective contraception - You have other medical conditions that would put you at risk 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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