Pfizer’s danuglipron shows promising results in Phase 2b obesity trial

Pfizer Inc. (NYSE: PFE) has announced encouraging topline data from its Phase 2b clinical trial (NCT04707313) investigating danuglipron, an oral Glucagon-like peptide-1 receptor agonist (GLP-1RA), in adults with obesity but without type 2 diabetes. The study successfully met its primary endpoint, showing a statistically significant change in body weight from baseline.

Effective Weight Reductions Observed in Danuglipron Study

The twice-daily dosing of danuglipron led to significant reductions in body weight at all doses tested, with mean reductions ranging from -6.9% to -11.7% at 32 weeks, compared to +1.4% for placebo. Placebo-adjusted reductions in mean body weight varied between -8% to -13% at 32 weeks. These results highlight danuglipron’s potential effectiveness in weight management.

Adverse Events and Safety Profile

While common adverse events were mild and gastrointestinal, high rates of nausea, vomiting, and diarrhea were observed. Despite these effects, the treatment with danuglipron did not increase the incidence of liver enzyme elevation compared to placebo. The detailed data from this study will be shared at a future scientific conference or in a peer-reviewed journal.

Future Prospects and Development Plans

Mikael Dolsten, Chief Scientific Officer & President, Pfizer Research and Development, expressed optimism about a once-daily formulation of danuglipron. Pfizer’s ongoing and future studies aim to improve tolerability and explore the full potential of danuglipron in obesity treatment.

Danuglipron’s Role in Diabetes and Obesity Treatment

Previous studies of danuglipron in type 2 diabetes and obesity have shown promising results, with dose-dependent reductions in HbA1c, fasting plasma glucose, and body weight. Pfizer’s focus remains on developing danuglipron as a robust treatment option for obesity and related conditions.

Study Design and Methodology

The Phase 2b randomized, double-blind, placebo-controlled study assessed the efficacy and safety of danuglipron across different cohorts with fixed titration schedules and target doses. Participants in the study were required to follow a fixed titration scheme according to their treatment group.

Danuglipron: An Investigational Oral Medicine

Danuglipron (PF-06882961) is currently an experimental medicine and has not been approved for use. Developed in-house at Pfizer, it represents a new class of medication for maintaining healthy blood sugar levels and managing obesity.