New York- Pfizer Inc. has announced promising topline data from its Phase 2b clinical trial (NCT04707313) evaluating the oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes. The study achieved its primary endpoint, demonstrating a statistically significant change in body weight from baseline.
The twice-daily dosing of danuglipron exhibited notable reductions from baseline in body weight for all doses, ranging from -6.9% to -11.7%, compared to +1.4% for placebo at 32 weeks, and -4.8% to -9.4%, compared to +0.17% for placebo at 26 weeks. Placebo-adjusted reductions in mean body weight ranged from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks.
While observing common mild gastrointestinal adverse events, such as nausea (up to 73%), vomiting (up to 47%), and diarrhea (up to 25%), the study noted higher discontinuation rates, exceeding 50% across all doses compared to approximately 40% with placebo. No new safety signals were reported, and treatment with danuglipron did not exhibit an increased incidence of liver enzyme elevation compared to placebo.
“We believe an improved once-daily formulation of danuglipron could play an important role in the obesity treatment paradigm, and we will focus our efforts on gathering the data to understand its potential profile,” said Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development. “Results from ongoing and future studies of the once-daily danuglipron modified release formulation will inform a potential path forward with an aim to improve the tolerability profile and optimize both study design and execution.”
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The future development of danuglipron will pivot towards a once-daily formulation, with anticipated pharmacokinetic data in the first half of 2024. Previously published results underscored its positive impact in reducing HbA1c, fasting plasma glucose, and body weight, indicating a promising prospect for addressing type 2 diabetes and obesity. As Pfizer continues to advance its research, the company remains dedicated to enhancing the potential of danuglipron in upgrading obesity treatment.
