Modification of feeding behaviour

• US 20060189522A1
• Filed: 01/12/2004
• Published: 08/24/2006
• Est. Priority Date: 01/10/2003
• Status: Abandoned Application

• Current Assignee: Imperial Innovations Limited (Imperial College London)
• Original Assignee: Imperial Innovations Limited (Imperial College London)
• Inventors: Small, Caroline Jane, Ghatei, Mohammad Ali, Bloom, Stephen Robert, Dakin, Catherine Louise
• Application Number:
  US10/541,526
• Publication Number:
  US 20060189522A1
• Time in Patent Office: Days
• US Class Current: 514/4.900
• 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 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/2271 Neuropeptide Y
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics

Abstract

The present invention relates to compositions and methods for use in the prevention or treatment of excess weight in a mammal. The compositions comprise oxyntomodulin which is shown to reduce food intake and/or increase energy expenditure.

Claims

1-37. -37. (canceled)

38. A pharmaceutical composition comprising oxyntomodulin and one or more additional agents which influence weight and/or food intake.

39. The composition of claim 38, wherein the composition is in a form suitable for administration via a route peripheral to the brain.

40. The composition of claim 39, wherein the composition is in a form suitable for administration by a route selected from the group consisting of oral, rectal, intravenous, intramuscular, intraperitoneal, buccal, sublingual, nasal, subcutaneous and transdermal administration.

41. The composition of claim 38, wherein the one or more additional agents have one of more effects selected from the group consisting of reduces food intake, reduces hunger, reduces weight, reduces or prevents obesity, increases energy expenditure and reduces nutrient availability in a mammal.

42. The composition of claim 38, wherein the one or more additional agents are selected from the group consisting of GLP-1 or an agonist thereof;

PYY or an agonist thereof; and

a combination of PYY or an agonist thereof and GLP-1 or an agonist thereof.

43. The composition of claim 42, wherein the composition is in a form suitable for peripheral administration and wherein the one or more additional agents are in a dose of 0.1 nmoles per kg body weight of the subject or more, for example, 0.2 nmoles or more, for example, 0.4 nmoles or more, for example, 0.6 nmoles or more, for example, 0.8 nmoles or more, for example, 1.0 nmole or more, for example, 1.2 nmoles or more, for example, 1.4 nmoles or more, for example, 1.6 nmoles or more, for example, 1.8 nmoles or more, for example, 2.0 nmoles or more, for example, 2.2 nmoles or more, for example, 2.4 nmoles or more, for example, 2.6 nmoles or more, for example, 2.8 nmoles or more, for example, 3.0 nmoles or more, for example, up to 3.2 nmoles per kg body weight.

44. The composition of claim 42, wherein the composition is in a form suitable for peripheral administration, and wherein the one or more additional agents are in a dose of up to 3.0 nmoles per kg body weight, for example, up to 2.8 nmoles, for example, up to 2.6 nmoles, for example, up to 2.4 nmoles, for example, up to 2.2 nmoles, for example, up to 2.0 nmoles, for example, up to 1.8 nmoles, for example, up to 1.4 nmoles, for example, up to 1.2 nmoles, for example, up to 1.0 nmoles, for example, up to 0.8 nmoles, for example, up to 0.6 nmoles, for example, up to 0.4 nmoles, for example, up to 0.2 nmoles per kg body weight.

45. The composition of claim 38, wherein the composition is in a form suitable for peripheral administration, and wherein the oxyntomodulin is in a dose of for example, 0.1 nmoles or more per kg body weight of the subject, for example, 0.2 nmoles or more, for example, 0.5 nmoles or more, for example, 1 nmole or more, for example, 1.5 nmoles or more, for example, 2 nmole or more, for example, 2.5 nmoles or more, for example, 3 nmoles or more, for example, 4 nmoles or more, for example, 5 nmoles or more, for example, 6 nmoles or more, for example, 7 nmoles or more, for example, 8 nmoles or more, for example, 9 nmoles or more, for example, 10 nmoles, for example, 11 nmoles or more, for example, up to 12 nmoles per kg body weight.

46. The composition of claim 38 in unit dosage form wherein the oxyntomodulin is in a dose of up to 11 nmoles per kg body weight, for example, up to 10 nmoles, for example, up to 9 nmoles, for example, up to 8 nmoles, for example, up to 7 nmoles, for example, up to 6 nmoles, for example, up to 5 nmoles, for example, up to 4 nmoles, for example, up to 3 nmoles, for example, up to 2 nmoles, for example, up to 1 nmole, for example, up to 0.5 nmoles, for example, up to 0.4 nmoles, for example, up to 0.2 nmoles per kg body weight.

47. The composition of claim 38, wherein the composition is in a form suitable for subcutaneous administration and wherein the dose of oxyntomodulin is from 0.5 mg to 2 mg.

48. A method for decreasing calorie intake in a subject, for decreasing appetite in a subject, for decreasing food intake in a subject, for increasing energy expenditure in a subject, for weight control or treatment in a subject, for reduction or prevention of obesity in a subject;

for preventing and reducing weight gain in a subject;

for inducing and promoting weight loss in a subject;

a method for reducing obesity as measured by the Body Mass Index;

a method for controlling of any one or more of appetite, satiety and hunger in a subject;

a method for maintaining desired body weight, a desired Body Mass Index, and/or a desired appearance and good health in a subject;

a method for improving lipid profile in a subject;

a method for alleviating a condition or disorder in a subject, which condition or disorder can be alleviated by reducing nutrient availability and/or by increasing energy expenditure;

or a method for reducing levels of circulating ghrelin in a subject, which comprises administering oxyntomodulin and one or more additional agents, which influence weight and/or food intake to the subject

49. The method of claim 48 for controlling any one or more of appetite, satiety and hunger in a subject which comprises inducing, increasing, enhancing or promoting satiety and/or sensations of satiety in a subject.

50. The method of claim 48 for controlling any one or more of appetite, satiety and hunger in a subject which comprises reducing, inhibiting or suppressing hunger or sensations of hunger in a subject.

51. The method of claim 48, wherein the effect is achieved by reducing levels of circulating ghrelin.

52. The method of claim 48, wherein the oxyntomodulin is administered via a route peripheral to the brain.

53. The method of claim 52, wherein the oxyntomodulin is administered by a route selected from the group consisting of oral, rectal, intravenous, intramuscular, intraperitoneal, buccal, sublingual, nasal, subcutaneous and transdermal administration.

54. The method of claim 48, wherein the one or more additional agents have an effect selected from the group consisting of reduces food intake and/or reduces hunger, reduces weight, reduces or prevents obesity, increases energy expenditure and reduces nutrient availability in a mammal.

55. The method of claim 54, wherein the one or more additional agents are selected from the group consisting of GLP-1 or an agonist thereof;

PYY or an agonist thereof; and

a combination of PYY or an agonist thereof and GLP-1 or an agonist thereof.

56. The method of claim 55, wherein the one or more additional agents are administered peripherally at a dose of 0.1 nmoles per kg body weight of the subject or more, for example, 0.2 nmoles or more, for example, 0.4 nmoles or more, for example, 0.6 nmoles or more, for example, 0.8 nmoles or more, for example, 1.0 nmole or more, for example, 1.2 nmoles or more, for example, 1.4 nmoles or more, for example, 1.6 nmoles or more, for example, 1.8 nmoles or more, for example, 2.0 nmoles or more, for example, 2.2 nmoles or more, for example, 2.4 nmoles or more, for example, 2.6 nmoles or more, for example, 2.8 nmoles, for example, 3.0 nmoles or more, for example, up to 3.2 nmoles per kg body weight.

57. The method of claim 55, wherein the one or more additional agents are administered peripherally in an amount of up to 3.0 nmoles per kg body weight, for example, up to 2.8 nmoles, for example, up to 2.6 nmoles, for example, up to 2.4 nmoles, for example, up to 2.2 nmoles, for example, up to 2.0 nmoles, for example, up to 1.8 nmoles, for example, up to 1.4 nmoles, for example, up to 1.2 nmoles, for example, up to 1.0 nmole, for example, up to 0.8 nmoles, for example, up to 0.6 nmoles, for example, up to 0.4 nmoles, for example, up to 0.2 nmoles per kg body weight.

58. The method of claim 48, wherein the oxyntomodulin is administered peripherally at a dose of, for example, 0.1 nmoles or more per kg body weight of the subject, for example, 0.2 nmoles or more, for example, 0.5 nmoles or more, for example, 1 nmole or more, for example, 1.5 nmoles or more, for example, 2 nmole or more, for example, 2.5 nmoles or more, for example, 3 nmoles or more, for example, 4 nmoles or more, for example, 5 nmoles or more, for example, 6 nmoles or more, for example, 7 nmoles or more, for example, 8 nmoles or more, for example, 9 nmoles or more, for example, 10 nmoles or more, for example, 11 nmoles or more, for example, up to 12 nmoles per kg body weight.

59. The method of claim 48, wherein the oxyntomodulin is administered at a dose of up to 11 nmoles per kg body weight, for example, up to 10 nmoles, for example, up to 9 nmoles, for example, up to 8 nmoles, for example, up to 7 nmoles, for example, up to 6 nmoles, for example, up to 5 nmoles, for example, up to 4 nmoles, for example, up to 3 nmoles, for example, up to 2 nmoles, for example, up to 1 nmoles, for example, up to 0.5 nmoles, for example, up to 0.4 nmoles, for example, up to 0.2 nmoles per kg body weight.

60. The method of claim 50, wherein the oxyntomodulin is administered at a dose of 0.5 mg to 2 mg before meals.

61. The method of claim 50, wherein the oxyntomodulin and the one or more additional agents are administered simultaneously, or sequentially in any order.