Tirzepatide pharmacokinetics and tolerability compared between autoinjector and prefilled syringe delivery

Tirzepatide is a dual GLP-1R and GIPR agonist demonstrating significant efficacy in type 2 diabetes and obesity management. Consistent drug exposure is paramount for optimizing therapeutic outcomes and patient safety. The method of drug delivery, particularly for self-administered injectables, can influence pharmacokinetics, patient adherence, and overall user experience. This study addresses the critical need to ensure that different administration devices provide equivalent drug exposure and tolerability, which is vital for widespread clinical adoption and patient choice.

This Phase 1 clinical trial investigated the comparative pharmacokinetics and tolerability of tirzepatide solution administered via two different subcutaneous delivery devices in healthy participants. The study aimed to assess the amount of tirzepatide entering the bloodstream and its elimination rate when delivered by an autoinjector versus a conventional prefilled syringe. Information on any adverse effects experienced was also collected to evaluate tolerability. Participants underwent screening within 28 days prior to study initiation, with each participant's total involvement lasting approximately 14 weeks.