Trazpiroben no better than placebo for treatment of idiopathic and diabetic gastroparesis

Key Results

Overall, 242 participants were enrolled (mean [standard deviation] age 55.7 [14.2] years; 75.6% female); 193 completed the study. No significant differences in change from baseline in weekly average of the daily diary composite score occurred at week 12 between placebo (least-squares mean [standard error] −1.19 [0.12]) and trazpiroben (5, 25, and 50 mg: −1.11 [0.22], −1.17 [0.12], and −1.21 [0.12], respectively). Overall, 41.4% of participants receiving trazpiroben reported treatment-emergent adverse events (placebo, 39.7%). No serious events were considered trazpiroben-related; no life-threatening or fatal events were reported.

There was no clinically meaningful difference in efficacy between trazpiroben and placebo in treating gastroparesis, based on the primary endpoint analysis. Trazpiroben was well tolerated with no new safety concerns identified, strengthening evidence supporting its favorable safety profile.

Reference:

Tack, J, McCallum, R, Kuo, B, et al. Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK-906) for idiopathic or diabetic gastroparesis. Neurogastroenterology & Motility. 2023; 00:e14652. doi:10.1111/nmo.14652

Keywords:

Trazpiroben, better, placebo, treatment, idiopathic, diabetic gastroparesis, Tack, J, McCallum, R, Kuo, B, Neurogastroenterology & Motility