A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron ( PF ‐06882961), an oral small‐molecule glucagon‐like peptide‐1 receptor agonist, in Japanese adults with type 2 diabetes mellitus
Authors' conclusion
In Japanese adults with T2DM, danuglipron exhibited dose-proportional increases in plasma exposure at steady state and robustly reduced glycaemic parameters and body weight after 8 weeks of dosing, with a safety profile consistent with the mechanism of action.
Study context
- Population
- Adult Japanese participants with T2D inadequately controlled on diet and exerciserandomized
- Participants
- 37 participants
- Comparison
- Danuglipron vs placebo
- Primary endpoint
- Safety and tolerability of danuglipron
Methodological detailsphase 1, double-blind, placebo-controlled, parallel-group, multiple ascending doses
- Phase 1
- Double-blind
- Placebo-controlled
- Parallel-group
- Multiple ascending doses
Primary result
As reported in the abstract
Safety and tolerability
- Most common treatment-emergent AEs: nausea, vomiting, abdominal discomfort, diarrhoea and headache
- Most treatment-emergent AEs were of mild or moderate intensity
Further findings
| Outcome | Least squares mean placebo-adjusted difference (up to) (mg/dl) (90% CI) | |
|---|---|---|
| Mean daily glucose, change from baseline · Day 56Significant reduction | −67.89 (−88.98 to −46.79) | |
| FPG, change from baseline · Day 57Significant reduction | −40.87 (−53.77 to −27.98) | |
| −100−50050Difference, mg/dl (linear scale) |
| Outcome | Least squares mean placebo-adjusted difference (up to) (90% CI) | |
|---|---|---|
| HbA1c, change from baseline · Day 57Significant reduction | −1.41% (−2.01% to −0.82%) | |
| −3−2−101Difference (linear scale) |
| Outcome | Least squares mean placebo-adjusted difference (up to) (kg) (90% CI) | |
|---|---|---|
| Body weight, change from baseline · Day 57Significant reduction | −1.87 (−3.58 to −0.17) | |
| −4−202Difference, kg (linear scale) |
Pharmacokinetics · steady state (Day 56)
- Dose-proportional increases in danuglipron exposure parameters
Safety
Treatment-emergent AEs
- Most common: nausea, vomiting, abdominal discomfort, diarrhoea and headache; mostly mild or moderate
Original publication
A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron ( PF ‐06882961), an oral small‐molecule glucagon‐like peptide‐1 receptor agonist, in Japanese adults with type 2 diabetes mellitus. Diabetes Obes Metab. Published 19 December 2022. doi:10.
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