Could a Diabetes Drug Be First Approved Tx for NASH?
A medication indicated to treat type 2 diabetes could be a future therapeutic option for non-alcoholic steatohepatitis (NASH) after a study presented at the 50th International Liver Congress in Vienna, Austria met its primary endpoint of histological clearance of NASH, and a reduction in the progression of fibrosis.
The Liraglutide Efficacy and Action in NASH (LEAN) trial enrolled 52 overweight patients and randomized them to receive a 48-week treatment with once-daily subcutaneous injections of either 1.8mg liraglutide or placebo. The primary outcome was improvement in liver histology, defined as “resolution of definite NASH” and no worsening in fibrosis from baseline to end-of-treatment. Forty-five patients underwent end-of-treatment biopsies.
Of the patients on liraglutide, 39% had resolution of definite NASH with no worsening of fibrosis vs. 9% in the placebo group; the liraglutide group also had greater reductions in weight, BMI, and fasting glucose. Only 9% of liraglutide patients experienced worsening of fibrosis compared to 26% taking placebo and no drug-related adverse events were reported in patients on liraglutide.
Liraglutide is currently indicated as adjunct to diet and exercise to improve glycemic control in type 2 diabetes. Presently there are no medications approved by the Food and Drug Administration (FDA) to treat NASH. A Phase 3 trial is needed to confirm these results.
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