Theravance Inc. and Alfa Wassermann S.p.A. announced the initiation of a Phase 2 proof-of-concept study with velusetrag, Theravance's investigational 5-HT4 agonist, for the treatment of patients with diabetic or idiopathic gastroparesis. Study 0093 is a multicenter, randomized, double-blind, incomplete block, three-period fixed sequence crossover, Phase 2 study. This proof-of-concept study will assess three oral doses of velusetrag (5, 15, and 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in approximately 32 patients with diabetic or idiopathic gastroparesis.

The primary endpoint of the study is gastric emptying time. Secondary endpoints include safety and tolerability assessments.