Additional Relevant Details
ORION is a randomized, double-blind, placebo-controlled study exploring the metabolic effects of cenicriviroc (CVC) in obese adults (BMI greater than or equal to 30 kg/m2) with prediabetes or diabetes and suspected non-alcoholic fatty liver disease (NAFLD). The primary outcome of ORION will measure changes in insulin sensitivity in peripheral and adipose tissue over a 24-week period and will include an interim analysis at 12 weeks. Tobira plans to announce the top-line 12-week interim analysis in the second quarter of 2016 and submit results for presentation at a scientific conference.

In obese patients, the over-expression of CCR2 and CCR5 receptors and their ligands in fat tissue has been shown to promote both inflammation and insulin resistance. Insulin resistance is associated with the development of NAFLD and is a key driver for disease progression to its more severe form, non-alcoholic steatohepatitis (NASH), as well as other diabetes-related complications.