Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
NCT07385547
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Type II Diabetes Mellitus
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- Sun Pharmaceutical Industries Limited
- Last updated on ClinicalTrials.gov
- March 13, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Florida · 1
- Panax Clinical Research · Miami Lakes, FL
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.