Method for treatment or prevention of obesity

• US 5,597,797 A
• Filed: 11/19/1993
• Issued: 01/28/1997
• Est. Priority Date: 06/07/1990
• Status: Expired due to Term

• Current Assignee: Genentech, Inc. (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Clark, Ross G.
• Primary Examiner(s): Schain, Howard E.
• Assistant Examiner(s): TOUZEAU, LYNN
• Application Number:
  US08/150,090
• Time in Patent Office: 1,166 Days
• Field of Search: 514/12, 514/21
• US Class Current: 514/6.9
• 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 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61K 38/30 Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 insulin-like growth factor binding protein A61K38/1754
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system

Abstract

A method is disclosed for treating obese mammals or preventing obesity from occurring in mammals. This method involves administering to the mammal an effective amount of growth hormone in combination with an effective amount of IGF-I. Preferably, the growth hormone is given so as to have a maintained, continual therapeutically effective presence in the blood, such as by continuous infusion or frequent injections, or by use of a long-acting formulation.

Claims

1. A method for reducing total body fat mass in an obese mammal comprising administering to the mammal an effective amount of IGF-I and growth hormone.

2. The method of claim 1 wherein the mammal is a human.

3. The method of claim 2 wherein the human has Type II diabetes and the need of the human for insulin is decreased upon the administration of growth hormone and IGF-I.

4. The method of claim 2 wherein the growth hormone is human native-sequence, mature growth hormone.

5. The method of claim 2 wherein the IGF-I is human native-sequence, mature IGF-I.

6. The method of claim 4 wherein the IGF-I is human native-sequence, mature IGF-I.

7. The method of claim 1 wherein the administration of IGF-I is be continuous infusion.

8. The method of claim 1 wherein the IGF-I is in a sustained- release formulation.

9. The method of claim 1 wherein the administration of growth hormone is by injection.

10. The method of claim 1 wherein the growth hormone is administered such that its therapeutically effective concentration is maintained continuously in the blood of the mammal for the duration of the period of its administration.

11. The method of claim 10 wherein the administration of growth hormone is by continuous infusion.

12. The method of claim 10 wherein the growth hormone is in a sustained-release formulation.

13. The method of claim 10 wherein the growth hormone is covalently conjugated via up to ten amino acid residues to a water-soluble polymer selected from the group consisting of polyethylene glycol homopolymers and polyoxyethylene polyols.

14. The method of claim 10 wherein the growth hormone is covalently conjugated to polyethylene glycol via 2 to 8 lysine residues on the growth hormone.

15. The method of claim 1 wherein the growth hormone is administered with a growth hormone binding protein.

16. The method of claim 1 wherein the effective amount of growth hormone is at least 0.01 mg/kg/day.

17. the method of claim 1 wherein the effective amount of IGF-I is at least 0.01 mg/kg/day.

18. The method of claim 1 wherein the growth hormone and IGF-I are administered separately.

19. The method of claim 1 wherein the growth hormone and IGF-I are administered as a single formulation.

20. The method of claim 1 wherein the IGF-I is administered with an IGF binding protein.