Pfizer has announced that its Phase IIb trial investigating oral weight loss drug danuglipron has met its primary endpoint.
The glucagon-like peptide-1 receptor agonist (GLP-1RA) was able to demonstrate a significant weight reduction in patients without type 2 diabetes. However, Pfizer does not plan to advance the evaluated twice-daily formulation into further Phase III studies.
The trial (NCT04707313) results showed that patients dosed twice daily with danuglipron saw weight reductions from baseline of between 8% to 13% after 32 weeks, and 5% to 9% after 26 weeks. This is compared to the placebo group, where some participants saw a general weight gain of 1.4% at week 32.
However, high rates of common gastrointestinal and mechanism-based adverse events were observed in the treatment groups. Also, greater than 50% of discontinuation rates were observed across all doses compared to the placebo group’s 40%.
While Pfizer did not provide details on the decision to not pursue the twice-daily regimen, Dr. Mikael Dolsten, chief scientific officer at Pfizer, 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.” The company is conducting a pharmacokinetic study with a once-daily version of the drug that will provide guidance on the future development plans.
Pfizer noted that this is consistent with the drug’s mechanism and that no new safety signals were reported.
GlobalData’s Pharmaceutical Intelligence Centre details how danuglipron is facing a large number of market competitors, with 341 similar drugs marketed for obesity, with a further 16 currently in Phase III trials. The drug is forecasted to reach total annual sales of $148m by the end of 2028, with that figure expected to grow to $369m by the end of 2029.
GlobalData is the parent company of Clinical Trials Arena.
Danuglipron is also being investigated in a number of other clinical trials in indications ranging from renal failure to liver fibrosis and type 2 diabetes.
The drug will find itself competing in a quickly expanding market as companies such as Novo Nordisk is ramping up the production of its drug Ozempic (semaglutide), which is predicted to make 14.6bn by the end of 2024.
It also follows after another competitor, Boehringer Ingelheim, announced that it was moving to Phase III with its GLP-1 weight loss drug survodutide.
GlobalData forecasts the global weight loss market is set to reach $37.1bn by the end of 2031.
Update: This second and fourth paragraphs have been updated to reflect Pfizer’s decision to not pursue the development of the twice-daily formulation studied in the Phase IIb trial.
