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

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.

NCT Number	NCT07385547
Lead Sponsor	Sun Pharmaceutical Industries Limited
Conditions	Type II Diabetes Mellitus
Enrollment	40 participants
Start Date	2026-02-25
Primary Completion	2026-09 (estimated)
Study Completion	2026-09-27 (estimated)
Updated on ClinicalTrials.gov	2026-03-13