Pfizer’s Danuglipron Phase IIb Trial Achieves Weight Loss Goals Amid Tolerability Concerns

Pfizer (NYSE: PFE) announced last week that its Phase IIb trial evaluating danuglipron, a glucagon-like peptide-1 (GLP-1) receptor agonist, in adults with obesity but without type 2 diabetes (T2D) has successfully met its primary endpoint. The study demonstrated significant reductions in body weight from baseline, with participants achieving placebo-adjusted mean weight losses ranging from 5% to 9.5% after 26 weeks and 8% to 13% after 32 weeks.

Despite these promising results, the twice-daily oral regimen was associated with notable gastrointestinal side effects, including nausea, vomiting, diarrhea, and treatment discontinuation rates of up to 73%, 47%, 25%, and over 50%, respectively. In response, Pfizer is pivoting to a once-daily modified release formulation aimed at enhancing tolerability, with the first pharmacokinetic data anticipated in the first half of 2024.- Flcube.com

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