Condition: Type II Diabetes Mellitus · Sponsor: Sun Pharmaceutical Industries Limited
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.
This description comes directly from the study's public registry record.
Head Regulatory Affairs · 9122 66455645 · Clinical.Trial@sunpharma.com
Always discuss trial participation with your own doctor first.
| Syneos Miami | Miami, Florida, United States | Not Yet Recruiting |
| Panax Clinical Research | Miami Lakes, Florida, United States | Recruiting |
| Orlando Clinical Research Center (OCRC) | Orlando, Florida, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07385547