Topline phase IIb results of oral GLP-1R agonist, danuglipron, in adults with obesity. - Pfizer.
Pfizer Inc. announced topline data from the Phase II clinical trial (NCT04707313) investigating its oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes.
The study met its primary endpoint demonstrating statistically significant change in body weight from baseline. Twice-daily dosing of danuglipron showed statistically significant reductions from baseline in body weight for all doses, with mean reductions 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. Depending on titration schedule, participants were at target dose levels for 6 to 24 weeks.
While the most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed (up to 73% nausea; up to 47% vomiting; up to 25% diarrhea). High discontinuation rates, greater than 50%, were seen across all doses compared to approximately 40% with placebo. No new safety signals were reported and treatment with danuglipron was not associated with increased incidence of liver enzyme elevation compared to placebo. Data from this study will be presented at a future scientific conference or published in a peer-reviewed journal.
About Phase IIb Study Design (NCT04707313) The Phase IIb randomized, double-blind, placebo-controlled, parallel group, dose-ranging study evaluated the efficacy and safety of danuglipron (PF-06882961) administration in adults with obesity and without type 2 diabetes. The study evaluated three cohorts across different fixed titration schedules and target doses. Cohorts 1 and 2 (n=497) evaluated one-week and two-week titration steps over 26 weeks with target doses at 40mg, 80mg, 120mg, 160mg and 200mg twice-daily. Cohort 3 (n=129) evaluated four-week titration steps over 32 weeks with target doses at 80mg, 140mg and 200mg twice-daily. The study utilized a titration protocol where participants were required to follow a fixed titration scheme, according to their randomized treatment group.
Pfizer has now announced that it is stopping development of a twice-daily oral obesity medication , danuglipron, after an underwhelming clinical trial, a set back to the company’s efforts to compete in the booming field of weight-loss medications. Danuglipron, met its primary target in the placebo-controlled Phase IIb trial, leading to a statistically significant amount of weight lost, the company said. But the weight reductions were smaller than those seen in trials of rival medicines targeting the same GLP-1 pathway, and a high rate of patients experienced side effects and dropped out of the trial.
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