Semaglutide for use in medicine

Abstract

The present invention is directed to use of the GLP-1 receptor agonist semaglutide in medical therapy for the treatment of non-alcoholic steatohepatitis.

1 . A method of treating non-alcoholic steatohepatitis (NASH), comprising administrating an effective amount of semaglutide to a subject in need thereof. 
     
     
         2 . The method according  claim 1 , wherein the subject has liver fibrosis stage 1, liver fibrosis stage 2, or liver fibrosis stage 3, wherein the liver fibrosis stage is classified according to the Kleiner fibrosis classification. 
     
     
         3 . The method according to  claim 1 , wherein the subject has liver fibrosis stage 2 or liver fibrosis stage 3. 
     
     
         4 . The method according to  claim 1 , wherein the method further comprises chronic management of NASH. 
     
     
         5 . The method according to  claim 1 , wherein the semaglutide is the sole active ingredient administered to the subject. 
     
     
         6 . The method according to  claim 1 , wherein the semaglutide is administered by subcutaneous administration. 
     
     
         7 . The method according to  claim 1 , wherein the semaglutide is administered in an amount in the range of about 0.7 to about 5 mg per week. 
     
     
         8 . The method according to  claim 7 , wherein the semaglutide is administered in an amount in the range of about 2.0 to about 3.5 mg per week. 
     
     
         9 . The method according to  claim 8 , wherein the semaglutide is administered in an amount of about 2.4 mg per week. 
     
     
         10 . The method according to  claim 9 , wherein the semaglutide is administered in an amount of 2.4 mg per week. 
     
     
         11 . The method according to  claim 8 , wherein the semaglutide is administered in an amount of about 2.8 mg per week. 
     
     
         12 . The method according to  claim 11 , wherein the semaglutide is administered in an amount of 2.8 mg per week. 
     
     
         13 . The method according to  claim 1 , wherein the semaglutide is administered once daily or less frequent. 
     
     
         14 . The method according to  claim 13 , wherein the semaglutide is administered once weekly. 
     
     
         15 . The method according to  claim 1 , wherein the method provides no worsening of liver fibrosis in the subject. 
     
     
         16 . The method according to  claim 1 , wherein the semaglutide is administered in a pharmaceutical composition in the form of an aqueous solution comprising one or more pharmaceutically acceptable excipients. 
     
     
         17 . The method according to  claim 16 , wherein the pharmaceutical composition is an aqueous solution comprising about 1.0 mg/ml semaglutide, about 1.42 mg/ml disodium hydrogen phosphate dihydrate, about 14.0 mg/ml propylene glycol, about 5.50 mg/ml phenol, and is at a pH of about 7.4. 
     
     
         18 . A method of treating non-alcoholic steatohepatitis (NASH), comprising administrating an effective amount of semaglutide to a subject in need thereof, wherein the subject has liver fibrosis stage 2 or liver fibrosis stage 3, wherein the liver fibrosis stage is classified according to the Kleiner fibrosis classification, and wherein the semaglutide is administered in an amount in the range of about 0.7 to about 5 mg per week. 
     
     
         19 . The method according to  claim 18 , wherein the semaglutide is administered in an amount in the range of about 2.0 to about 3.5 mg per week. 
     
     
         20 . The method according to  claim 19 , wherein the semaglutide is administered in an amount of about 2.4 mg per week. 
     
     
         21 . The method according to  claim 20 , wherein the semaglutide is administered in an amount of 2.4 mg per week. 
     
     
         22 . The method according to  claim 18 , wherein the semaglutide is administered in an amount of about 2.8 mg per week. 
     
     
         23 . The method according to  claim 22 , wherein the semaglutide is administered in an amount of 2.8 mg per week. 
     
     
         24 . The method according to  claim 20 , wherein the semaglutide is administered once weekly. 
     
     
         25 . The method according to  claim 21 , wherein the semaglutide is administered once weekly. 
     
     
         26 . The method according to  claim 22 , wherein the semaglutide is administered once weekly. 
     
     
         27 . The method according to  claim 23 , wherein the semaglutide is administered once weekly.