METHODS AND COMPOSITIONS FOR FACILITATING WEIGHT LOSS BY ADMINISTRATION OF THYROID HORMONES

• US 20130005814A1
• Filed: 06/29/2012
• Published: 01/03/2013
• Est. Priority Date: 07/01/2011
• Status: Abandoned Application

• Current Assignee: Carol N. Rowsemitt, Thomas Najarian
• Original Assignee: Carol N. Rowsemitt, Thomas Najarian
• Inventors: Najarian, Thomas, Rowsemitt, Carol N.
• Application Number:
  US13/537,853
• Publication Number:
  US 20130005814A1
• Time in Patent Office: Days
• US Class Current: 514/567
• 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 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents

Abstract

The present invention provides methods and compositions for facilitating weight loss in subjects who are undergoing a weight loss regimen by administration of thyroid hormones, for example, T₂ alone, T₂ in combination with T₃, T₂ in combination with T₃ and T₄, or T₃ in combination with T₄. In particular, subjects who have already experienced weight loss often are unable to continue to lose weight as the body experiences a famine response, i.e., hypothyroidism. By administration of the compositions of the present invention, for example, T₂ alone, T₂ in combination with T₃, T₂ in combination with T₃ and T₄, or T₃ in combination with T₄, subjects are able to return thyroid levels to normal and/or to reduce the levels of rT₃ to normal, so as to allow the body to continue to lose weight.

Claims

1. A method for facilitating or continuing weight loss in a subject undergoing a weight loss regimen, the method comprising administering to the subject T₂, T₂ in combination with T₃, T₂ in combination with T₃ and T₄, or T₃ in combination with T₄, in an amount effective to increase the level of circulating thyroid hormone in the subject or to reduce the level of circulating rT₃ hormone to normal, thereby facilitating or continuing weight loss in the subject.

4. The method of claim 1, wherein the subject has a reduced level of circulating thyroid hormone prior to administration of the thyroid hormone or as compared to the level of circulating thyroid hormone prior to starting the weight loss regimen.

6. The method of claim 4, wherein the subject has a reduced level of circulating T₃, circulating T₄ or a combination thereof.

7. The method of claim 1, wherein the subject has elevated levels of circulating rT₃ prior to administration of the thyroid hormone.

8. The method of claim 1, wherein the subject has experienced weight loss prior to administration of the thyroid hormone.

11. The method of claim 1, wherein the weight loss regimen comprises dieting, exercise, weight loss surgery and/or appetite control medication.

13. The method of claim 1, wherein the subject is administered T₂ alone.

27. The method of claim 1, wherein at least one of T₂, T₃ and T₄ is administered in a sustained release composition.

28. The method of claim 1, wherein the combination of T₂ and T₃;

T₂, T₃ and T₄;

or T₃ and T₄ are provided in a single formulation.

29. The method of claim 28, wherein the formulation is a sustained release formulation.

2. A method for alleviating or preventing a thyroid abnormality in a subject undergoing a weight loss regimen, the method comprising administering to the subject T₂, T₂ in combination with T₃, T₂ in combination with T₃ and T₄, or T₃ in combination with T₄, in an amount effective to increase the level of circulating thyroid hormone in the subject or to reduce the level of circulating rT₃ hormone to normal, thereby alleviating or preventing a thyroid abnormality in the subject.

3. The method of claim 2, wherein the thyroid abnormality is selected from the group consisting of elevated diastolic blood pressure, low blood pressure, elevated lipid levels, coldness, cold extremities, fatigue, insomnia, muscle aches, joint aches, hair loss, constipation, depression and a combination thereof.

5. (canceled)

9-10. -10. (canceled)

12. (canceled)

14-26. -26. (canceled)

30-31. -31. (canceled)

32. A pharmaceutical composition for facilitating weight loss, comprising T₃ and T₄;

T₂, T₃ and T₄;

T₂ and T₃;

or T₂; and

a pharmaceutically acceptable carrier.

33. The pharmaceutical composition of claim 32, wherein the composition is a sustained release composition.

35. The pharmaceutical composition of claim 32, comprising T₂, T₃ and T₄ and a pharmaceutically acceptable carrier.

36. The pharmaceutical composition of claim 35, wherein the composition is a sustained release composition.

37. The pharmaceutical composition of claim 32, comprising T₂ and T₃;

and a pharmaceutically acceptable carrier.

38. The pharmaceutical composition of claim 37, wherein the composition is a sustained release composition.

45. The pharmaceutical composition of claim 32, comprising T₂, and a pharmaceutically acceptable excipient.

46. The pharmaceutical composition of claim 45, wherein the composition is a sustained release formulation.

34. (canceled)

39-44. -44. (canceled)

47-55. -55. (canceled)