Methods of treating an overweight or obese subject

Abstract

The invention herein generally relates to pharmaceutical formulations and methods of treating an overweight or obese subject, and overweight- or obesity-related conditions.

What is claimed is: 
     
         1 . A method of treating an overweight or obese subject, the method comprising:
 administering to the subject in need thereof, an amount of fumagillin, fumagillol, or fumagillin ketone, or derivatives thereof, or salts, esters or prodrugs of these, effective to result in weight loss in the subject, wherein the amount administered does not substantially reduce lean body mass of the subject.   
     
     
         2 . The method according to  claim 1 , wherein the amount of fumagillin, fumagillol, or fumagillin ketone, or derivatives thereof, or salts, esters or prodrugs of these, administered to the subject is selected from the group consisting of: about 1 g/day, 500 mg/day, about 250 mg/day, about 100 mg/day, about 50 mg/day, about 25 mg/day, about 10 mg/day, about 5 mg/day, about 3 mg/day, about 2 mg/day, about 1 mg/day, about 0.75 mg/day, about 0.5 mg/day, about 0.1 mg/day, about 0.05 mg/day, and about 0.01 mg/day. 
     
     
         3 . The method according to  claim 1 , wherein the subject is a human. 
     
     
         4 . The method according to  claim 1 , wherein the subject is a vetinary ammonal selected from the group consisting of a cat or a dog. 
     
     
         5 . The method according to  claim 3 , wherein the subject has a Body Mass Index measurement selected from the group consisting of: at least about 25 kg/m 2 , at least about 30 kg/m 2 , and at least about 40 kg/m 2 . 
     
     
         6 . The method according to  claim 5 , wherein the subject has an overweight- or obesity-related condition. 
     
     
         7 . The method according to  claim 6 , wherein the overweight- or obesity-related related condition is selected from the group consisting of: a cardiac disorder, an endocrine disorder, a respiratory disorder, a hepatic disorder, a skeletal disorder, a psychiatric disorder, a metabolic disorder, and a reproductive disorder. 
     
     
         8 . The method according to  claim 3 , wherein the subject has a BMI of at least about 35 kg/m 2  and an overweight- or obesity-related condition. 
     
     
         9 . A method of treating an overweight- or obesity-related condition, the method comprising: administering to a subject in need thereof, a therapeutically effective amount of fumagillin, fumagillol, or fumagillin ketone, or derivatives thereof, or salts, esters or prodrugs of these, wherein the amount administered does not substantially reduce lean body mass of the subject. 
     
     
         10 . The method according to  claim 9 , wherein the amount administered ameliorates or eliminates the obesity related condition. 
     
     
         11 . The method according to  claim 10 , wherein the amount of fumagillin, or salt or ester thereof, administered to the subject is selected from the group consisting of: about 1 g/day, about 500 mg/day, about 250 mg/day, about 100 mg/day, about 50 mg/day, about 25 mg/day, about 10 mg/day, about 5 mg/day, about 3 mg/day, about 2 mg/day, about 1 mg/day, about 0.75 mg/day, about 0.5 mg/day, about 0.1 mg/day, about 0.05 mg/day, and about 0.01 mg/day. 
     
     
         12 . The method according to  claim 9 , wherein the subject is a human. 
     
     
         13 . The method according to  claim 9 , wherein the subject is a vetinary ammonal selected from the group consisting of a cat or a dog. 
     
     
         14 . The method according to  claim 12 , wherein the subject has a Body Mass Index measurement selected from the group consisting of: at least about 25 kg/m 2 , at least about 30 kg/m 2 , and at least about 40 kg/m 2 . 
     
     
         15 . The method according to  claim 9 , wherein the overweight- or obesity-related condition is selected from the group consisting of: a cardiac disorder, an endocrine disorder, a respiratory disorder, a hepatic disorder, a skeletal disorder, a psychiatric disorder, a metabolic disorder, and a reproductive disorder. 
     
     
         16 . A method of treating an overweight or obese subject, the method comprising:
 administering to the subject in need thereof, fumagillin, fumagillol, or fumagillin ketone, or derivatives thereof, or salts, esters or prodrugs of these, in an amount of at most about 1 g/day, wherein the amount administered results in weight loss in the subject.   
     
     
         17 . A method of treating an overweight- or obesity-related condition, the method comprising: administering to the subject in need thereof, fumagillin, fumagillol, or fumagillin ketone, or derivatives thereof, or salts, esters or prodrugs of these, in an amount of at most about 1 g/day, wherein the amount administered treats the overweight- or obesity-related condition. 
     
     
         18 . A method for facilitating and maintaining weight loss in a subject, the method comprising: administering to the subject an amount of fumagillin, fumagillol, or fumagillin ketone, or derivatives thereof, or salts, esters or prodrugs of these, effective to result in weight loss in the subject; and administering a therapeutically effective amount of a weight loss agent to maintain a reduced weight in the subject. 
     
     
         19 . The method according to  claim 18 , wherein administering is simultaneously. 
     
     
         20 . The method according to  claim 18 , wherein administering is sequentially. 
     
     
         21 . The method according to  claim 20 , wherein the fumagillin, fumagillol, or fumagillin ketone, or derivatives thereof, or salts, esters or prodrugs of these are intravenously administered for a first period of time, and the weight loss agent is orally administered for a second period of time. 
     
     
         22 . The method according to  claim 18 , wherein the weight loss agent is selected from the group consisting of: serotonin and noradrenergic re-uptake inhibitors; noradrenergic re-uptake inhibitors; selective serotonin re-uptake inhibitors; and intestinal lipase inhibitors. 
     
     
         23 . The method according to  claim 18 , wherein the weight loss agent is selected from the group consisting of orlistat, sibutramine, methamphetamine, ionamin, phentermine, bupropion, diethylpropion, phendimetrazine, benzphetermine, and topamax.