NCT07385547

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	GL0034	Subcutaneous (SC) administration of a single dose of GL0034

Timeline

• Start date: 2026-02-25
• Primary completion: 2026-09-01
• Completion: 2026-09-27
• First posted: 2026-02-04
• Last updated: 2026-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study