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.
Participant is willing and able to sign a written or electronic informed consent.
Participant is an adult male or female, aged between 18 and 80 years of age, inclusive, at the time of screening.
eGFR ≥ 90 mL/min;
eGFR ≥ 30-59 mL/min;
Participant has a screening calcitonin ≥ 50 ng/L (pg/mL).
Participant is on continuous renal replacement therapy or peritoneal dialysis.
Participant has a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome (MENS) type 2.
Participant has a history of pancreatitis (acute or chronic).
Single group
GL0034
DrugSubcutaneous (SC) administration of a single dose of GL0034
Single dose PK exposure parameters: Maximum concentration (Cmax)
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)
Single dose PK exposure parameters: AUC from time zero extrapolated to infinite time (AUC0-i)
Adverse events (AEs) leading to trial discontinuation and serious adverse events (SAEs).
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