Danuglipron: Research & Evidence
Emerging EvidencePublished research, clinical trial data, and evidence grading for Danuglipron across studied indications.
Back to Danuglipron overviewResearch Summary
Danuglipron has completed Phase 2b testing in obesity (NCT04707313, N=610) showing 8-13% placebo-adjusted weight loss at 32 weeks, and Phase 2 in Type 2 diabetes (NCT04034303, N=411) demonstrating glycemic control. The initial twice-daily formulation had high GI adverse event rates, prompting development of a once-daily formulation that met PK objectives in dose-optimization studies (NCT06567327, NCT06568731). No observed liver enzyme elevations across 1,400+ participants. Phase 3 trials with the optimized once-daily formulation are anticipated. Not FDA-approved as of March 2026.
Evidence by Indication (3 indications)
| Indication | Tier | Trials | Summary |
|---|---|---|---|
| Obesity/weight loss | Tier B | 1 | Phase 2b RCT (N=610) showed 8-13% weight loss at 32 weeks |
| Type 2 diabetes | Tier B | 1 | Phase 2 RCT (N=411) demonstrated glycemic control |
| MASH/NAFLD | Tier D | 0 | No trials — theoretical benefit from GLP-1 class |
Graded using our evidence tier methodology.
Higher score = larger gap between therapeutic potential and available clinical evidence.
Citations (2 sources)
- 1. Phase 2b trial of danuglipron in adults with obesity Clinical Trial
Pfizer Clinical Trial Investigators (2025), Obesity
- 2. Phase 2 trial of danuglipron in Type 2 diabetes Clinical Trial
Pfizer Clinical Trial Investigators (2023), Diabetes Care