Liraglutide formulation comparison aims for bioequivalence in healthy volunteers

Liraglutide is a widely used GLP-1 receptor agonist for Type 2 Diabetes Mellitus and obesity. Optimizing drug formulations is crucial for consistent efficacy, safety, and patient convenience, especially for long-term treatments. Minor changes in pH or excipients can impact drug stability, absorption, and bioavailability, potentially altering its pharmacokinetic profile. Ensuring bioequivalence across different formulations is a regulatory requirement to guarantee that new versions deliver the same therapeutic effect as established ones, preventing unexpected variations in patient response. This trial specifically addresses the need to confirm that updated formulations maintain the established profile of liraglutide.

This trial compared three liraglutide formulations (pH 7.7, 7.9, and 8.15) in healthy volunteers. The study aimed to establish bioequivalence between the two new formulations (pH 7.9 and 8.15) and a planned Phase 3 formulation (pH 7.7). It was conducted in Oceania. Specific details on randomization, blinding, sample size, dosing regimen, or primary pharmacokinetic endpoints (AUC, Cmax) are not provided in the available record.