Liver disease

Abstract

Methods of treating a liver disease or condition, or a symptom thereof, in a subject in need of treatment, are disclosed and described. One method comprises orally administering to a subject, a pharmaceutical composition having an amount of a testosterone, or an ester thereof, sufficient to treat the liver disease or condition, or symptom thereof.

What is claimed is: 
     
         1 . A method of treating non-alcoholic steatohepatitis, or a symptom thereof, in a subject in need of treatment, said method comprising orally administering to a subject a pharmaceutical composition having an amount of a testosterone ester sufficient to treat non-alcoholic steatohepatitis (NASH). 
     
     
         2 . The method of  claim 1 , wherein said method ameliorates a level of one or more biomarkers in said subject compared to a baseline value. 
     
     
         3 . The method of  claim 1 , wherein the subject is a male. 
     
     
         4 . The method of  claim 1 , wherein the subject has low testosterone or testosterone deficiency prior to commencing therapy. 
     
     
         5 . The method of  claim 1 , wherein the subject has at least one or more biomarkers of a liver disease or condition in an upper normal range or above. 
     
     
         6 . The method of  claim 1 , wherein said subject has at least one or more biomarkers of a liver disease or condition elevated above an upper normal limit. 
     
     
         7 . The method of  claim 1 , wherein said method reduces said subject's level of serum alkaline phosphatase levels compared to said subject's baseline value. 
     
     
         8 . The method of  claim 1 , wherein said treatment prolongs an amount of time the subject can wait for a liver transplant or survive. 
     
     
         9 . The method of  claim 1 , wherein the amount of testosterone ester is from 10 mg to 5000 mg per day. 
     
     
         10 . The method of  claim 1 , wherein the testosterone ester is chosen from testosterone undecanoate, testosterone tridecanoate, testosterone dodecanoate, or a combination thereof. 
     
     
         11 . The method of  claim 1 , wherein the pharmaceutical composition comprises a vitamin E, a vitamin E prodrug, a vitamin E derivative, or an omega-3 fatty acid. 
     
     
         12 . The method of  claim 5 , wherein the one or more biomarkers are chosen from ALP, ALT, AST, GGT, triglycerides, LDL, cholesterol, liver biopsy, inflammation biomarkers, non-HDL cholesterol, hematocrit, hemoglobin, lipoprotein phospholipase A2, bilirubin, albumin, SHBG, imaging biomarkers, liver histology biomarkers, biomarkers in the literature related to the disease and condition described herein, and liver damage biomarkers. 
     
     
         13 . The method of  claim 1 , wherein said subject in need of treatment has one, two, or three, or more co-morbid diseases or conditions chosen from obesity, type 2 diabetes, dyslipidemia, cardiovascular disease, thyroid dysfunction, chronic kidney disease, liver disease, osteoporosis, hypogonadism, hypertension, sarcopenia, and cachexia. 
     
     
         14 . The method of  claim 1 , comprising oral administration of 200 mg to 750 mg of testosterone undecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         15 . The method of  claim 1 , comprising oral administration of 300 mg to 600 mg of testosterone undecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         16 . The method of  claim 1 , comprising oral administration of 450 mg of testosterone undecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         17 . The method of  claim 1 , comprising oral administration of 400 mg to 2000 mg of testosterone tridecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         18 . The method of  claim 1 , comprising oral administration of 600 mg to 1800 mg of testosterone tridecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         19 . The method of  claim 1 , comprising oral administration of 500 mg, 750 mg, 1000 mg, or 1250 mg of testosterone tridecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         20 . The method of  claim 1 , wherein said subject has an age chosen from 1 to 18 years old, 18-25 years old, 26-35 years old, 36-45 years old, 45-55 years old, 56-65 years old, or older than 65 years old. 
     
     
         21 . The method of  claim 1 , wherein said subject has NASH with fibrosis. 
     
     
         22 . The method of  claim 1 , wherein said subject has NASH with F2 or F3 fibrosis (NASH CRN scale). 
     
     
         23 . The method of  claim 1 , comprising oral administration of 100 mg to 200 mg of testosterone undecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         24 . The method of  claim 1 , comprising oral administration of 200 mg to 400 mg of testosterone undecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         25 . The method of  claim 1 , comprising oral administration of 5 mg to 100 mg of testosterone undecanoate per day to said subject wherein the subject is an adult male subject. 
     
     
         26 . The method of  claim 1 , further comprising treating said subject with one or more additional pharmaceuticals agents suitable for treating liver disease, a comorbidity of liver disease, or symptoms thereof.