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

Sun Pharmaceutical Industries Limited

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.

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: 1. Participant is willing and able to sign a written or electronic informed consent. 2. Participant is an adult male or female, aged between 18 and 80 years of age, inclusive, at the time of screening. 3. Participant has eGFR as defined by CKD-EPI equation and converted to the unit of mL/min according to the following ranges: * eGFR ≥ 90 mL/min; * eGFR ≥ 30-59 mL/min; * eGFR \< 30 mL/min, not on dialysis; * eGFR \< 30 mL/min, on intermittent hemodialysis. 4. Participant has a body mass index ≥ 18 kg/m2 and ≤ 42 kg/m2 at the Screening visit. 5. Contraception re…

Interventions

Drug
GL0034
Subcutaneous (SC) administration of a single dose of GL0034

Locations (3)

Syneos Miami
Miami, Florida
Panax Clinical Research
Miami Lakes, Florida
Orlando Clinical Research Center (OCRC)
Orlando, Florida