Compositions and methods for treating non-alcoholic steatohepatitis

1. A method for treating or alleviating non-alcoholic steatohepatitis (NASH), comprising administering to a human subject a self-emulsifying composition that comprises: eicosapentaenoic acid, ethyl eicosapentanoate, or a combination thereof; and an emulsifier,

wherein the administering results in one or more of:

an increase of at least 1% to about 95% of serum adiponectin concentration;

an increase of 1% to about 90% of albumin concentration;

a reduction of at least 1% to about 50% of glycated hemoglobin (HbA1c) concentration;

a reduction of 1% to about 90% of alkaline phosphatase (ALP) concentration;

a reduction of at least 1% to about 95% of Type IV collagen 7S concentration; or

a reduction of at least 1% to about 95% of hyaluronic acid concentration;

in the human subject administered with the self-emulsifying composition.

2. The method of claim 1 , wherein the administering further results in one or more of:

at least 1% increase of interleukin-10 (IL-10) concentration;

at least 1% reduction of small dense LDL concentration; or

a concentration reduction of at least 1% to about 95% of one or more of:

interleukin-2 (IL-2);

interleukin-3 receptor alpha chain;

apolipoproteinA-IV;

apolipoproteinC-II;

chemokine (C-C motif) ligand 2 (CCL2);

thrombospondin 1 (TSP1);

lymphocyte antigen 6 complex, locus D;

matrix metallopeptidase 12 (MMP12);

matrix metallopeptidase 13 (MMP13);

trehalase;

tissue inhibitor of metalloproteinase 1 (TIMP1);

procollagen type I alpha 1 (COL1A1);

tumor necrosis factor receptor (TNFR) superfamily member 19;

tumor necrosis factor alpha induced protein 6 (TNFAIP6);

very low density lipoprotein receptor (VLDLR);

lipoprotein lipase;

eosinophil associated ribonuclease (EAR) A family, member 1;

EAR A family, member 2;

EAR A family, member 3; or

EAR A family, member 12;

in the human subject administered with the self-emulsifying composition.

3. The method of claim 1 , wherein the administering occurs during a meal.

4. The method of claim 1 , wherein the administering occurs after a meal.

5. The method of claim 1 , wherein the administering occurs within 30 minutes after a meal.

6. The method of claim 1 , wherein the administering occurs at a timing other than during, after, or immediately after a meal.

7. The method of claim 1 , wherein the human subject is not diabetic.

8. The method of claim 1 , wherein the human subject is not taking any anti-diabetic drug.

9. The method of claim 1 , wherein the human subject is a possible or definite NASH subject.

10. The method of claim 1 , wherein the administering continues for 3, 6, 9, or 12 months.

11. The method of claim 1 , wherein the administering provides a dosage of ethyl eicosapentanoate at about 0.3-10 g per day.

12. The method of claim 1 , wherein the administering provides a dosage of ethyl eicosapentanoate at 0.6-6 g per day.

13. The method of claim 1 , wherein the administering provides a dosage of ethyl eicosapentanoate at 0.9-3.6 g per day.

14. The method of claim 1 , wherein the administering provides a dosage of ethyl eicosapentanoate at about 1800-2700 mg per day.

15. The method of claim 1 , wherein the administering provides a dosage of ethyl eicosapentanoate at about: 1800 mg or 2700 mg per day.

16. The method of claim 1 , wherein the administering provides a dosage of ethyl eicosapentanoate at one, two, or three times per day.

17. The method of claim 1 , wherein the administering provides a dosage of ethyl eicosapentanoate at 600 mg or 900 mg three times per day.

18. The method of claim 1 , wherein the administering results in an increase of at least 1% to about 95% of serum adiponectin concentration in the human subject.

19. The method of claim 1 , wherein the administering results in an increase of 1% to about 90% of albumin concentration in the human subject.

20. The method of claim 1 , wherein the administering results in a reduction of at least 1% to about 50% of HbA1c concentration in the human subject.

21. The method of claim 1 , wherein the administering results in a reduction of 1% to about 90% of ALP concentration in the human subject.

22. The method of claim 1 , wherein the administering results in a reduction of at least 1% to about 95% of Type IV collagen 7S concentration in the human subject.

23. The method of claim 1 , wherein the administering results in a reduction of at least 1% to about 95% of hyaluronic acid concentration in the human subject.