The topline data showed statistically significant change in body weight from baseline with danuglipron administration with changes at all dosages compared to placebo
Pfizer’s danuglipron delivered mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks. (Credit: Pfizer Inc.)
Pfizer said that danuglipron (PF-06882961) has met the primary endpoint in a Phase 2b clinical trial of adults with obesity and without type 2 diabetes.
Danuglipron is an experimental oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate.
The topline data showed a statistically significant change in body weight from baseline with danuglipron administration.
It showed changes at all dosages, mean drops ranged from -6.9% to -11.7% at 32 weeks, compared to +1.4% for a placebo, and from -4.8% to -9.4% at 26 weeks, compared to +0.17% for a placebo.
The mean body weight reductions that were corrected for placebo were between -8% and -13% at 32 weeks and -5% to -9.5% at 26 weeks.
For six to twenty-four weeks, participants were at target dosage levels, depending on the titration plan, the American pharmaceutical major said.
The common adverse events were mild and gastrointestinal in nature, which is similar to the mechanism, and with no new safety signals observed.
Furthermore, the treatment with the experimental candidate was not related to increased incidence of liver enzyme elevation compared to placebo.
Pfizer research and development chief scientific officer and president Mikael Dolsten said: “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.
“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 optimise both study design and execution.”
The Phase 2b randomised, double-blind, placebo-controlled, parallel group, dose-ranging trial assessed the safety and efficacy of the GLP-1RA candidate.
It evaluated three cohorts with varying fixed titration regimens and target doses.
Over 26 weeks, cohorts 1 and 2 assessed one-week and two-week titration steps in 497 patients with target doses of 40mg, 80mg, 120mg, 160mg, and 200mg twice daily.
Cohort 3 assessed four-week titration steps with target dosages of 80mg, 140mg, and 200mg twice daily over 32 weeks in 129 patients.
Previously, the Phase 2 study of danuglipron in type 2 diabetes showed positive results.