Semaglutide ER injectable suspension to assess safety, tolerability, and pharmacokinetics in healthy adults

The global prevalence of Type 2 Diabetes Mellitus (T2DM) continues to rise, necessitating effective and convenient treatment options. Glucagon-like peptide-1 receptor (GLP-1R) agonists like semaglutide are highly effective, but current formulations often require frequent administration. Developing an extended-release (ER) injectable suspension could enhance patient adherence and improve glycemic control by reducing dosing frequency. This study aims to characterize the pharmacokinetic profile and safety of a novel semaglutide ER formulation, addressing a critical need for improved drug delivery in T2DM management.

This is a planned open-label, single-dose, dose-escalation Phase 1 study. 14 healthy adult participants will receive a single subcutaneous (SC) dose of Semaglutide Extended-release Injectable Suspension at either 1 mg, 4 mg, or 8 mg under fasting conditions. The primary endpoints include maximum plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t), alongside comprehensive safety and tolerability assessments. The study is designed to characterize the pharmacokinetic profile across these escalating doses.

This study is currently 'NOT_YET_RECRUITING' and is estimated to begin in August 2024, with completion anticipated in November 2024. Therefore, no findings or results are available at this time. The study aims to collect data on the pharmacokinetic parameters, including Cmax and AUC0-t, for single doses of semaglutide ER injectable suspension at 1 mg, 4 mg, and 8 mg in healthy adult subjects. Safety and tolerability will also be assessed across these dose levels.