Compositions and methods for treating or preventing obesity in a subject in need thereof
View Patent ↗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.
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, 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.