Shionogi assessed the long-term efficacy and safety of velneperit over the course of one year in two distinct studies, comprising a total randomized population of 1,566 obese subjects across 80 centers in the US. Each respective study assessed the efficacy and safety of velneperit under different reduced calorie diet and low calorie diet conditions.
In the strongest performing group relative to placebo across the two studies, subjects undergoing velneperit treatment of 800mg once-daily in combination with a reduced calorie diet responded with 5% or greater weight loss at a percentage nearly three times higher than those on placebo (35% versus 12%).
In addition, velneperit treatment resulted in statistically significant differences with respect to secondary parameters such as decreased waist circumference and improved serum lipid profile, said Shionogi.
In terms of safety, velneperit was well tolerated in all groups over the course of one year treatment, a finding consistent with subject experience in previous clinical studies. These clinical studies further demonstrate the potential for the NPY Y5 receptor as a target for obesity treatment, the company added.
A full analysis of the current study data, including secondary efficacy endpoints as well as safety and laboratory parameters is currently underway.
Isao Teshirogi, president and representative director of Shionogi, said: Based on these results, we will continue to further investigate the potential of velneperit in our ongoing clinical program, including exploring other settings or regimens where velneperit treatment can demonstrate maximal benefit. In addition, we will accelerate pursuit of additional NPY Y5 receptor antagonist candidates.