Pfizer Inc. announced that based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies. The ongoing open-label, randomized study is evaluating the pharmacokinetics and safety of immediate- and modified release formulations of danuglipron administered orally in healthy adults 18 years or older.

To date, study results have demonstrated a pharmacokinetic profile supportive of once-daily dosing. with a safety profile consistent with prior danuglipron studies including no liver enzyme elevations observed in more than 1,400 study participants. Danuglipron (PF-06882961) is an investigational medicine that is taken as a tablet by mouth and is not approved for use by health authorities at this time.

Danuglipron, which was discovered and developed in-house at Pfizer, is a type of investigational medicine known as a GLP-1 receptor agonist. This investigational medicine is intended to keep blood sugar at healthy levels and work by increasing the amount of insulin released. Other potential effects include slowing down the digestion of food and increasing the feeling of fullness after eating, which may be associated with weight loss.