Claims for Patent: 6,956,026

Summary for Patent: 6,956,026

Title:	Use of exendins for the reduction of food intake
Abstract:	Methods for treating conditions or disorders which can be alleviated by reducing food intake are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist, alone or in conjunction with other compounds or compositions that affect satiety. The methods are useful for treating conditions or disorders, including obesity, Type II diabetes, eating disorders, and insulin-resistance syndrome. The methods are also useful for lowering the plasma glucose level, lowering the plasma lipid level, reducing the cardiac risk, reducing the appetite, and reducing the weight of subjects. Pharmaceutical compositions for use in the methods of the invention are also disclosed.
Inventor(s):	Beeley; Nigel Robert Arnold (Solana Beach, CA), Bhavsar; Sunil (San Diego, CA)
Assignee:	Amylin Pharmaceuticals, Inc. (San Diego, CA)
Application Number:	09/003,869
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,956,026
Patent Claims:	1. A method for reducing food intake in a subject desirous or in need of reducing food intake, comprising peripherally administering to said subject an amount of an exendin effective to reduce food intake. 2. The method according to claim 1, wherein said peripheral administration is by injection. 3. The method according to claim 1, wherein said peripheral administration is selected from the group consisting of intravenous administration, intraperitoneal administration, subcutaneous administration, intramuscular administration, oral administration, topical administration, transmucosal administration, and pulmonary administration. 4. The method according to claim 1, wherein about 10 .mu.g/70 kg to about 5 mg/70 kg of the exendin is administered per day in single or divided doses. 5. The method according to claim 1, wherein about 10 .mu.g/70 kg to about 2 mg/70 kg of the exendin is administered per day in single or divided doses. 6. The method according to claim 1, wherein about 10 .mu.g/70 kg to about 500 .mu.g/70 kg of the exendin is administered per day in single or divided doses. 7. The method according to claim 1, wherein about 0.1 .mu.g/kg to about 100 .mu.g/kg of the exendin is administered per day in single or divided doses. 8. The method according to claim 1, wherein about 0.1 .mu.g/kg to about 10 .mu.g/kg of the exendin is administered per day in single or divided doses. 9. The method according to claim 1, wherein about 0.1 .mu.g/kg to about 1 .mu.g/kg of the exendin is administered per day in single or divided doses. 10. The method of claim 1, wherein said subject is human. 11. The method of claim 1, wherein said subject suffers from Type II diabetes. 12. The method of claim 1, wherein said subject suffers from an eating disorder. 13. The method of claim 1, wherein said subject suffers from an insulin-resistance syndrome. 14. The method of claim 1, wherein said exendin is exendin-3. 15. The method of claim 1, wherein said exendin is exendin-4. 16. The method of claim 1, further comprising administering a therapeutically effective amount of one or more compounds selected from the group consisting of an amylin agonist, a leptin, and a cholecystokinin (CCK). 17. A method for reducing appetite in a subject desirous or in need of reducing appetite, comprising peripherally administering to said subject an amount of an exendin effective to reduce appetite. 18. The method according to claim 17, wherein said peripheral administration is by injection. 19. The method according to claim 17, wherein said peripheral administration is selected from the group consisting of intravenous administration, intraperitoneal administration, subcutaneous administration, intramuscular administration, oral administration, topical administration, transmucosal administration, and pulmonary administration. 20. The method according to claim 17, wherein about 10 .mu.g/70 kg to about 5 mg/70 kg of the exendin is administered per day in single or divided doses. 21. The method according to claim 17, wherein about 10 .mu.g/70 kg to about 2 mg/70 kg of the exendin is administered per day in single or divided doses. 22. The method according to claim 17, wherein about 10 .mu.g/70 kg to about 500 .mu.g/70 kg of the exendin is administered per day in single or divided doses. 23. The method according to claim 17, wherein about 0.1 .mu.g/kg to about 100 .mu.g/kg of the exendin is administered per day in single or divided doses. 24. The method according to claim 17, wherein about 0.1 .mu.g/kg to about 10 .mu.g/kg of the exendin is administered per day in single or divided doses. 25. The method according to claim 17, wherein about 0.1 .mu.g/kg to about 1 .mu.g/kg of the exendin is administered per day in single or divided doses. 26. The method of claim 17, wherein said subject is human. 27. The method of claim 17, wherein said subject suffers from Type II diabetes. 28. The method of claim 17, wherein said subject suffers from an eating disorder. 29. The method of claim 17, wherein said subject suffers from an insulin-resistance syndrome. 30. The method of claim 17, wherein said exendin is exendin-3. 31. The method of claim 17, wherein said exendin is exendin-4. 32. The method of claim 17, further comprising administering a therapeutically effective amount of one or more compounds selected from the group consisting of an amylin agonist, a leptin, and a cholecystokinin (CCK). 33. A method for reducing food intake in a subject desirous or in need of reducing food intake comprising peripherally administering to said subject an amount of exendin-4 effective to reduce food intake. 34. The method according to claim 33, wherein said peripheral administration is by injection. 35. The method according to claim 33, wherein said peripheral administration is selected from the group consisting of intravenous administration, intraperitoneal administration, subcutaneous administration, intramuscular administration, oral administration, topical administration, transmucosal administration, and pulmonary administration. 36. The method according to claim 33, wherein about 10 .mu.g/70 kg to about 5 mg/70 kg of the exendin-4 is administered per day in single or divided doses. 37. The method according to claim 33, wherein about 10 .mu.g/70 kg to about 2 mg/70 kg of the exendin-4 is administered per day in single or divided doses. 38. The method according to claim 33, wherein about 10 .mu.g/70 kg to about 500 .mu.g/70 kg of the exendin-4 is administered per day in single or divided doses. 39. The method according to claim 33, wherein about 0.1 .mu.g/kg to about 100 .mu.g/kg of the exendin-4 is administered per day in single or divided doses. 40. The method according to claim 33, wherein about 0.1 .mu.g/kg to about 10 .mu.g/kg of the exendin-4 is administered per day in single or divided doses. 41. The method according to claim 33, wherein about 0.1 .mu.g/kg to about 1 .mu.g/kg of the exendin-4 is administered per day in single or divided doses. 42. The method of claim 33, wherein said subject is human. 43. The method of claim 33, wherein said subject suffers from Type II diabetes. 44. The method of claim 33, wherein said subject suffers from an eating disorder. 45. The method of claim 33, wherein said subject suffers from an insulin-resistance syndrome. 46. The method of claim 33, further comprising administering a therapeutically effective amount of one or more compounds selected from the group consisting of an amylin agonist, a leptin, and a cholecystokinin (CCK). 47. A method for reducing appetite in a subject desirous or in need of reducing appetite, comprising peripherally administering to said subject an amount of exendin-4 effective to reduce appetite. 48. The method according to claim 47, wherein said peripheral administration is by injection. 49. The method according to claim 47, wherein said peripheral administration is selected from the group consisting of intravenous administration, intraperitoneal administration, subcutaneous administration, intramuscular administration, oral administration, topical administration, transmucosal administration, and pulmonary administration. 50. The method according to claim 47, wherein about 10 .mu.g/70 kg to about 5 mg/70 kg of the exendin-4 is administered per day in single or divided doses. 51. The method according to claim 47, wherein about 10 .mu.g/70 kg to about 2 mg/70 kg of the exendin-4 is administered per day in single or divided doses. 52. The method according to claim 47, wherein about 10 .mu.g/70 kg to about 500 .mu.g/70 kg of the exendin-4 is administered per day in single or divided doses. 53. The method according to claim 47, wherein about 0.1 .mu.g/kg to about 100 .mu.g/kg of the exendin-4 is administered per day in single or divided doses. 54. The method according to claim 47, wherein about 0.1 .mu.g/kg to about 10 .mu.g/kg of the exendin-4 is administered per day in single or divided doses. 55. The method according to claim 47, wherein about 0.1 .mu.g/kg to about 1 .mu.g/kg of the exendin-4 is administered per day in single or divided doses. 56. The method of claim 47, wherein said subject is human. 57. The method of claim 47, wherein said subject suffers from Type II diabetes. 58. The method of claim 47, wherein said subject suffers from an eating disorder. 59. The method of claim 47, wherein said subject suffers from an insulin-resistance syndrome. 60. The method of claim 47, further comprising administering a therapeutically effective amount of one or more compounds selected from the group consisting of an amylin agonist, a leptin, and a cholecystokinin (CCK). 61. A method for reducing food intake in a subject desirous or in need of reducing body weight, comprising peripherally administering to said subject an amount of exendin-4 effective to lower a plasma lipid level. 62. The method according to claim 61, wherein said peripheral administration is by injection. 63. The method according to claim 61, wherein said peripheral administration is selected from the group consisting of intravenous administration intraperitoneal administration, subcutaneous administration, intramuscular administration, oral administration, topical administration, transmucosal administration, and pulmonary administration. 64. The method of claim 61, further comprising administering a therapeutically effective amount of one or more compounds selected from the group consisting of an amylin agonist, a leptin, and a cholecystokinin (CCK). 65. A method for reducing appetite in a subject desirous or in need of reducing body weight, comprising peripherally administering to said subject an amount of exendin-4 effective to lower a plasma lipid level. 66. The method according to claim 65, wherein said peripheral administration is by injection. 67. The method according to claim 65, wherein said peripheral administration is selected from the group consisting of intravenous administration, intraperitoneal administration, subcutaneous administration, intramuscular administration, oral administration, topical administration, transmucosal administration, and pulmonary administration. 68. The method of claim 65, further comprising administering a therapeutically effective amount of one or more compounds selected from the group consisting of an amylin agonist, a leptin, and a cholecystokinin (CCK).