Velusetrag Improves Bowel Movements in Diabetic or Idiopathic Gastroparesis

It was a multicentre, randomised, double-blind, placebo-controlled, three-period fixed-sequence crossover phase 2 study. The researchers included a total of 34 subjects with diabetic or idiopathic gastroparesis and assigned them to receive oral velusetrag (5, 15 or 30 mg) or placebo once daily for seven days each. The major outcome assessed was the proportion of subjects achieving ≥20% reduction in GE half-time (GE t1/2 ) from each treatment period baseline on day 7. They also assessed the absolute and per cent changes from baseline GE t1/2.They used [13 C]-octanoate breath test to measure GE. They further evaluated safety outcomes from treatment-emergent adverse events (TEAEs).

Key findings of the study were:

• Upon analysis, the researchers found that treatment with velusetrag 30 mg significantly increased the proportion of subjects with ≥20% reduction from baseline GE t1/2 compared with placebo (52% vs 5%), and GE t1/2 was numerically reduced following all three doses of velusetrag relative to placebo treatment.
• They observed similar efficacy between subjects with diabetic and idiopathic gastroparesis.
• They reported mild side-effects which were related to GI transit acceleration.

The authors concluded, "Velusetrag accelerates GE in subjects with diabetic or idiopathic gastroparesis and is generally well-tolerated in this population"

For further information:

https://onlinelibrary.wiley.com/doi/10.1111/apt.16344