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RECRUITING
NCT07385547
PHASE1

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

Sponsor: Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-25

Completion Date

2026-09-27

Last Updated

2026-03-13

Healthy Volunteers

Yes

Interventions

DRUG

GL0034

Subcutaneous (SC) administration of a single dose of GL0034

Locations (3)

Syneos Miami

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Orlando Clinical Research Center (OCRC)

Orlando, Florida, United States