Danuglipron
Oral SMD GLP-1 RA · Pfizer
Pivotal trial #
- Trial
- Phase 2b obesity
- Indication
- obesity (no T2D)
- Duration
- 32 weeks
- ClinicalTrials.gov
- NCT04707313
- Sponsor
- Pfizer
Notes #
Pfizer oral small-molecule GLP-1 RA (PF-06882961), twice-daily formulation. Phase 2b obesity (NCT04707313): cohort 3 (n=129) ran 32 weeks at 80/140/200 mg BID, with mean weight reductions of -6.9% to -11.7% (top dose) vs +1.4% placebo (placebo-adjusted -8% to -13%); cohorts 1-2 (n=497) ran 26 weeks. GI-heavy tolerability: nausea up to 73%, vomiting up to 47%, diarrhea up to 25%. All-cause discontinuation was >50% across all doses vs ~40% placebo - AE-led discontinuation was not separately disclosed, so danuglipron has no efficacy-vs-tolerability scatter point. Pfizer discontinued the twice-daily form in Dec 2023 and the entire danuglipron program on 14 Apr 2025 after one asymptomatic case of potential drug-induced liver injury (resolved on discontinuation) in a once-daily dose-optimization study. T2D Phase 2b: Saxena et al, JAMA Netw Open 2023 (16 wk, -4.17 kg at 120 mg BID).