Based on results from the ongoing pharmacokinetic study (NCT06153758), Pfizer Inc. 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.

“Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates. The most advanced of them, danuglipron, has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space,” said Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development. “Following a thorough analysis of our previous Phase 2b data and trial design, we believe that with the preferred modified release formulation and future trial design optimization, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity.”

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.