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

Part of paid clinical trials in Miami, Florida.

Sponsor
Sun Pharmaceutical Industries Limited
Study ID
NCT07385547
Phase
PHASE1
Status
Recruiting
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Conditions

  • Type II Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • GL0034 — DRUG
    Subcutaneous (SC) administration of a single dose of GL0034

Study Details

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.

Key Dates

Start date
Feb 25, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 27, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GL0034
    Single dose of GL0034

Primary Outcome Measure

Single dose PK exposure parameters: Maximum concentration (Cmax) [ Time Frame: From predose through 672 hours post-dose (multiple time points) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Syneos MiamiMiamiFlorida33136-
Panax Clinical ResearchMiami LakesFlorida33014-
Orlando Clinical Research Center (OCRC)OrlandoFlorida32809-

Find similar trials in Miami, FL

By research site
Syneos Miami· Miami, FLPanax Clinical Research· Miami Lakes, FLOrlando Clinical Research Center (OCRC)· Orlando, FL

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