A study conducted in patients with non-alcoholic steatohepatitis (NASH) showed that once-daily subcutaneous semaglutide resulted in a significantly higher percentage of patients with disease resolution compared to placebo, according to an article published in the New England Journal of Medicine.
The analysis included 320 patients, of whom 230 had a higher fibrosis stage (F2 or F3). The participants were randomised to receive semaglutide at a dose of 0.1 mg (80 patients), 0.2 mg (78 patients) or 0.4 mg (82 patients) or to receive placebo (80 patients). The primary endpoint was resolution of NASH with no worsening of fibrosis. The confirmatory secondary endpoint was an improvement of at least one fibrosis stage without worsening of NASH.
Among the patients with stage F2 or F3 fibrosis, a higher percentage of patients achieved NASH resolution with no worsening of fibrosis with semaglutide than placebo. However, semaglutide did not show a significant difference between groups in relation to the improvement of at least one fibrosis stage without worsening of NASH, which was unexpected.
The safety profile of subcutaneous semaglutide was consistent with that observed in patients with type 2 diabetes in other trials and with the known effects of GLP-1 receptor agonists.