Study S002554

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT07385547
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: RECRUITING
Enrollment: 40
Start: 2026-02-25
Primary completion: 2026-09
Lead sponsor: Sun Pharmaceutical Industries Limited
Conditions: Type II Diabetes Mellitus
Interventions: DRUG:GL0034
Results posted: FALSE

Registered primary outcomes

Single dose PK exposure parameters: Maximum concentration (Cmax) [From predose through 672 hours post-dose (multiple time points)]
Single dose PK exposure parameters: Area under the plasma concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t) [From predose through 672 hours post-dose (multiple time points)]
Single dose PK exposure parameters: AUC from time zero extrapolated to infinite time (AUC0-i) [From predose through 672 hours post-dose (multiple time points)]

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