Compositions and methods for treating or preventing obesity in a subject in need thereof

• US 10,206,898 B2
• Filed: 02/02/2016
• Issued: 02/19/2019
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Zakrzewski, Joseph S.
• Primary Examiner(s): Tran, My-Chau T.
• Application Number:
  US15/013,544
• Publication Number:
  US 20160143875A1
• Time in Patent Office: 1,113 Days
• Field of Search: 514549
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent obesity.

Claims

1. A method of treating and/or preventing obesity in a subject comprising, administering to the subject a pharmaceutical composition comprising about 2500 mg to 5000 mg per day of ethyl eicosapentaenoate and not more than about 5% docosahexaenoic acid or its esters, by weight of all fatty acids, for more than about 1 week and less than about 200 weeks to effect a reduction in one or more of:

BMI, body weight, waist measurement, and body fat percentage.

2. The method of claim 1 wherein the reduction is compared to baseline.

3. The method of claim 1 wherein the reduction is compared to placebo arm.

4. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in any one or more of:

BMI, body weight, waist measurement, and body fat percentage of at least 5%, at least 10%, at least 15%, or at least 20% compared to baseline or placebo control.

5. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 25% compared to placebo control.

6. The method of claim 1 wherein the subject further exhibits a reduction in one or more of:

fasting triglycerides, fasting LDL-C, fasting apolipoprotein B, hs-CRP, non-HDL-C, fasting VLDL-C, oxidized LDL, lipoprotein associated phospholipase A2, and total cholesterol, compared to baseline or placebo control.

7. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 500 mg to about 1.5 g of ethyl eicosapentaenoate.

8. The method of claim 7 wherein the dosage units are capsules.

9. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 900 mg to about 1 g of ethyl eicosapentaenoate.

10. The method of claim 9 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 1 g of ethyl eicosapentaenoate.

11. The method of claim 10 wherein the dosage units are capsules.

12. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids.

13. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 95%, by weight, of all fatty acids.

14. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 96%, by weight, of all fatty acids.

15. The method of claim 1 wherein the pharmaceutical composition is administered to the subject for about 1 week to about 15 weeks, or for about 1 week to about 12 weeks, or for about 12 weeks.