Pfizer (NYSE:PFE) announced on Friday that its investigating weight-loss pill, danuglipron, met its primary endpoint in a Phase 2b clinical trial evaluating its efficacy and safety of in adults with obesity and without type 2 diabetes.
Danuglipron, an oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, is intended to keep blood sugar at healthy levels by increasing the amount of insulin released and lowering the amount of glucagon released into the blood. The experimental medicine is also claimed to slow down the digestion of food and increase the feeling of fullness after eating.
In a placebo-controlled Phase 2b trial, the drug showed statistically significant change in body weight from baseline, with mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks.
While most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were seen (up to 73% nausea; up to 47% vomiting; up to 25% diarrhea), with high discontinuation rates observed across all doses.
Keeping these side effects in mind, the drugmaker has decided to focus on once-daily formulation in relation to future development of danuglipron. At this time, twice-daily danuglipron formulation will not advance into Phase 3 studies, said the firm in a statement.
“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 optimize both study design and execution,” said Mikael Dolsten, chief scientific officer & president, Pfizer R&D.
Shares of Pfizer (PFE) fell around 4% premarket in response to the news
Major durgmakers with oral weight loss drug in studies include: Eli Lilly (LLY) and Novo (NVO). Other relevant tickers include Amgen (AMGN) and Altimmune (ALT)
