$Pfizer (PFE.US)$ has decided to continue the clinical development of the oral late-stage glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate, danuglipron (PF-06882961), for adults with obesity and Type 2 diabetes mellitus.
The company plans to discontinue the clinical development of another GLP-1-RA candidate, lotiglipron (PF-07081532), due to pharmacokinetic data from Phase 1 studies and laboratory measurements of elevated transaminases (liver enzymes).
None of the participants reported liver-related symptoms, and there was no evidence of liver failure or need for treatment.
The announcement is "incrementally negative for perception" around Pfizer's weight loss drugs, Reuters noted, citing SVB Securities analyst David Risinger.
Demand for Wegovy and Ozempic from Novo Nordisk A/S (NYSE:NVO) for treating obesity and diabetes, respectively, has soared recently.
The demand for treatments like Wegovy could support as many as ten competing products, with annual sales reaching up to $100 billion within a decade, mostly in the U.S., industry executives and analysts have said.
Plans for the late-stage program of danuglipron are expected to be finalized by the end of 2023. The company is also working on a once-daily modified-release version of this drug.
Previously published results from the Phase 2 study of danuglipron in T2DM showed dose-dependent placebo-adjusted reductions in HbA1c, fasting plasma glucose, and body weight over 16 weeks.
The most common adverse events reported in this study were nausea, vomiting, and diarrhea.
The ongoing Phase 2b study of danuglipron in non-diabetic obesity participants is expected to complete by the end of the year.
Elevated transaminase levels have not been observed in the over 1,400 patients enrolled in the danuglipron program.