Efficacy and safety of danuglipron ( PF ‐06882961) in adults with obesity: A randomized, placebo‐controlled, dose‐ranging phase 2b study
Authors' conclusion
In participants with obesity, danuglipron resulted in statistically significant and clinically meaningful reductions in body weight versus placebo over 26 or 32 weeks. The overall safety profile observed in this study was consistent with expectations for the mechanism, although discontinuation rates due to AEs were higher than anticipated across all treatment groups, including placebo.
Study context
- Population
- Adults aged 18–75 years with obesity, without diabetes626 treated
- Participants
- 628 adults
- Comparison
- Danuglipron twice daily vs placebo
- Danuglipronn = 536
- Placebon = 90reference
- Primary endpoint
- Change in weight from baseline to end of treatment
- Follow-up
- End of treatment (26 or 32 weeks)
Methodological detailsdouble-blind, placebo-controlled, dose-ranging, phase 2b
- Double-blind
- Placebo-controlled
- Dose-ranging
- Phase 2b
Primary result
As reported in the abstract
Weight change from baseline, least squares mean % vs placebo · end of treatment
Each group vs placeboEstimate (90% CI)
Danuglipron
least squares mean percentage decrease (lowest across doses) −5.0%(−6.8% to −3.2%)
Danuglipron
least squares mean percentage decrease (highest across doses) −12.9%(−16.1% to −9.5%)
Further findings
Treatment completion
- Completed treatment
- 39.3%
Safety
Discontinuation and adverse events (AEs)
- Discontinued treatment because of AEs
- ≈38%
- Discontinued for other reasons
- 22%
- Most frequent events nausea and vomiting; GI AEs generally increased at higher doses; most mild; no other dose-related trends
Original publication
Efficacy and safety of danuglipron ( PF ‐06882961) in adults with obesity: A randomized, placebo‐controlled, dose‐ranging phase 2b study. Diabetes Obes Metab. Published 20 June 2025. doi:10.
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