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1. (WO2019032469) TREATMENT OF OVERWEIGHT AND OBESITY ASSOCIATED WITH LEPTIN DEFICIENCY
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WHAT IS CLAIMED:

1. A method of treating an above-normal weight condition in a subject with a leptin deficiency, the method comprising administering a therapeutically effective amount of leptin to the subject.

2. The method of claim 1, wherein the above-normal weight condition comprises overweight.

3. The method of claim 2, wherein overweight comprises a BMI of 25 kg/m2 to less than 30 kg/m2.

4. The method of claim 3, wherein overweight comprises a BMI of 27 kg/m2 to less than 30 kg/m2.

5. The method of claim 4, wherein overweight comprises a BMI of 27.5 kg/m2 to less than 30 kg/m .

6. The method of claim 1, wherein the above-normal weight condition comprises obesity.

7. The method of claim 6, wherein obesity comprises a BMI of 30 kg/m2 or greater.

8. The method of any one of claims 1-7, wherein the leptin deficiency comprises a pre-treatment serum leptin concentration of:

(i) < about 16 ng/mL, if the subject is female;

(ii) < about 5 ng/mL, if the subject is male.

9. The method of claim 8, wherein the leptin deficiency comprises a pre-treatment serum leptin concentration of:

(i) < about 8 ng/mL, if the subject is female;

(ii) < about 3 ng/mL, if the subject is male.

10. The method of claim 9, wherein the leptin deficiency comprises a pre-treatment serum leptin concentration of:

(i) < about 5 ng/mL, if the subject is female;

(ii) < about 2 ng/mL, if the subject is male.

11. The method of any one of claims 1-7, wherein the leptin deficiency comprises a pre-treatment serum leptin concentration that is in about the 10th percentile according to the third National Health and Nutrition Examination Survey (NHANES III).

12. The method of claim 11, wherein the leptin deficiency comprises a pre-treatment serum leptin concentration that is in about the 2nd percentile according to NHANES III.

13. The method of claim 12, wherein the leptin deficiency comprises a pre-treatment serum leptin concentration that is in about the 1st percentile according to NHANES III.

14. The method of any one of claims 1-13, wherein the subject has a detectable pre-treatment serum leptin concentration.

15. The method of any one of claims 1-14, wherein the subject has a weight-related comorbidity.

16. The method of claim 15, wherein the weight-related comorbidity is selected from the group consisting of prediabetes, type 2 diabetes mellitus, dyslipidemia, hypertension, cardiovascular disease, cancer, breathing disorders, gallbladder disease, gynecological problems, erectile dysfunction and sexual health issues, liver dysfunction, liver inflammation, or liver damage, osteoarthritis, and a combination thereof.

17. The method of claim 16, wherein the weight-related comorbidity is type 2 diabetes mellitus, hypertension, dyslipidemia, or a combination thereof.

18. The method of any one of claims 1-17, wherein the subject is human.

19. The method of any one of claims 1-18, wherein the subject is an adult human.

20. The method of any one of claims 1-19, wherein the subject pre-treatment does not have a high insulin level.

21. The method of any one of claims 1-20, wherein the subject pre-treatment does not have impaired glucose tolerance.

22. The method of any one of claims 1-21, wherein the subject pre-treatment does not have two or more of the following:

(i) high triglycerides or high HDL cholesterol

(ii) high blood pressure, or

(iii) high fasting glucose level.

23. The method of any one of claims 1 -22, wherein the subject does not have metabolic syndrome.

24. The method of any one of claims 1-23, wherein the subject does not have congenital leptin deficiency.

25. The method of any one of claims 1-24, wherein the leptin is methionyl-human leptin.

26. The method of any one of claims 1-25, wherein the therapeutically effective amount is about 1-50 mg/day

27. The method of claim 26, wherein the therapeutically effective amount is about 5-20 mg/day.

28. The method of any one of claims 1-27, wherein the leptin is administered once daily to the subject.

29. The method of any one of claims 1-27, wherein the leptin is administered twice daily to the subject.

30. The method of any one of claims 1-28, wherein the leptin is administered in an amount of about 20 mg once daily to the subject.

31. The method of any one of claims 1 -30, wherein the leptin is administered parenterally.

32. The method of claims 31, wherein the leptin is administered subcutaneously.

33. The method of any one of claims 1-32, wherein the administration of the leptin decreases body weight of the subject by about 5 % or greater from pre-treatment body weight.

34. The method of claim 33, wherein the administration of the leptin decreases body weight of the subject by about 10 % or greater from pre-treatment body weight.

35. The method of claim 33 or 34, wherein the decrease in body weight is maintained for about one week or longer.

36. The method of claim 35, wherein the decrease in body weight is maintained for about one month or longer.

37. The method of claim 36, wherein the decrease in body weight is maintained for about one year or longer.

38. The method of any one of claims 1-32, wherein the administration of the leptin reduces BMI of the subject by about 5 % or greater from pre-treatment BML

39. The method of claim 38, wherein the administration of the leptin reduces BMI of the subject by about 10 % or greater from pre-treatment BMI.

40. The method of claims 38 or 39, wherein the reduction in BMI is maintained for about one week or longer.

41. The method of claim 40, wherein the reduction in BMI is maintained for about one month or longer.

42. The method of claim 41, wherein the reduction in BMI is maintained for about one year or longer.

43. A method of treating an above-normal weight condition in a subject with a leptin deficiency, the method comprising subcutaneously administering a therapeutically effective amount of leptin to the subject, wherein:

(a) the subject is overweight and has a weight-related comorbidity, or the subject is obese; and

(b) the leptin deficiency comprises a pre-treatment serum leptin concentration of:

(i) < about 16 ng/mL, if the subject is female,

ii) < about 5 ng/mL, if the subject is male.

44. The method of claim 43, wherein the subject does not have congenital leptin deficiency.