Semaglutide + Empagliflozin combination therapy investigated for NASH in Type 2 Diabetes patients

Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD) characterized by liver inflammation and damage, often progressing to fibrosis, cirrhosis, and liver failure. It is highly prevalent in individuals with type 2 diabetes (T2D), exacerbating their metabolic and cardiovascular risks. Current treatment options for NASH are limited, with no FDA-approved pharmacotherapy specifically for the condition, especially in the context of T2D. This creates a significant unmet medical need, driving research into existing metabolic drugs like GLP-1 receptor agonists and SGLT2 inhibitors, which have shown benefits in T2D and related metabolic dysfunction.

This multicenter, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is designed to assess the effects of combination therapy or monotherapy. Patients with type 2 diabetes and NASH will be randomized into three groups: (1) combined semaglutide and empagliflozin, (2) empagliflozin monotherapy, or (3) placebo. The primary endpoint is to evaluate the impact of these treatments on NASH. Specific doses, routes, and durations for semaglutide and empagliflozin are not detailed in this abstract.