medwireNews: The sodium-glucose cotransporter (SGLT)1/2 inhibitor licogliflozin has reduced liver enzyme levels in people with nonalcoholic steatohepatitis (NASH) in a phase 2 trial published in Nature Medicine.
During 12 weeks of treatment, the highest dose of licogliflozin used – 150 mg/day – resulted in an average 32% reduction in serum alanine aminotransferase (ALT) versus placebo. The absolute reductions were 30.41 versus 8.77 U/L, and there were also significant reductions with the SGLT1/2 inhibitor in aspartate aminotransferase and gamma-glutamyl transferase.
In addition, the average liver fat reduction, of 38.7%, was significantly greater than that achieved with placebo, despite this being an “unusually robust” 21%, report Stephen Harrison (Pinnacle Clinical Research, San Antonio, Texas, USA) and study co-authors.
The 107 study participants were approximately 50 years of age, just over half were women, and about 20% had type 2 diabetes.
The most frequent adverse event was diarrhea, reported in 76.7% of the licogliflozin 150 mg group versus 42.9% of the placebo group. The researchers attribute the increased rate with licogliflozin to “SGLT1 inhibition within the gut,” and observe that just one person discontinued treatment because of diarrhea.
“Expanded clinical trials of licogliflozin alone, and in combination with drugs that have different mechanisms of action, are warranted to further determine the therapeutic potential of licogliflozin as a new therapeutic option for the treatment of patients with NASH,” the team concludes.
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