Composition and method for regulation of body weight and associated conditions

Abstract

Methods for regulating body weight and/or regulating weight gain are provided herein. The methods are useful, for instance, for treating or preventing obesity. Specifically, methods of administering varying levels of various alpha melanocyte stimulating hormone (α-MSH) analog compounds to an animal are provided for reducing body weight and/or reducing the rate of body weight gain.

1 - 33 . (canceled)  
     
     
         34 . A method of decreasing body weight or reducing the rate of weight gain in an animal, comprising the step of: 
 administering to the peripheral tissue of an animal a therapeutically effective amount of a melanocyte stimulating hormone (MSH) compound selected from the group consisting of α-MSH and α-MSH agonists.    
     
     
         35 . The method of claim  1  further comprising the step of measuring the decrease of body weight or the reduction of weight gain of the animal.  
     
     
         36 . The method of claim  1 , wherein the therapeutically effective amount is between about 0.1 μg and about 1 mg per day per kg of body weight of the animal.  
     
     
         37 . The method of claim  1 , wherein the therapeutically effective amount is between about 0.1 μg and about 100 μg per day per kg of body weight of the animal.  
     
     
         38 . The method of claim  1 , wherein the therapeutically effective amount is between about 40 μg and about 100 μg per day per kg of body weight of the animal.  
     
     
         39 . The method of claim  1 , wherein the therapeutically effective amount is insufficient to measurably change the appetite of the animal.  
     
     
         40 . The method of claim  1 , wherein the MSH compound is administered by a nasal, oral, topical, rectal, parenteral, subcutaneous, intradermal, intravenous, intraperitoneal, or an intramuscular route.  
     
     
         41 . The method of claim  1 , wherein the MSH compound is administered by an intraperitoneal route.  
     
     
         42 . The method of claim  1 , wherein further comprising the step of measuring the decrease of body weight or the reduction of weight gain of the animal; 
 a. wherein the therapeutically effective amount is between about 0.1 μg and about 1 mg per day per kg of body weight of the animal, and is insufficient to measurably change the appetite of the animal; and    b. wherein the MSH compound is administered by a nasal, oral, topical, rectal, parenteral, subcutaneous, intradermal, intravenous, intraperitoneal, or an intramuscular route.    
     
     
         43 . The method of claim  1 , wherein the MSH compound comprises a sequence of the formula: X aa   5 -His-X aa   7 -Arg-XX aa   9 , wherein 
 X aa   5  is selected from the group consisting of Asp and Glu;    X aa   7  is selected from the group consisting of Phe and D-Phe; and    X aa   9  is selected from the group consisting of Trp and D-Trp.    
     
     
         44 . The method of claim  1 , wherein the MSH compound comprises a sequence of the formula: -His-Phe-Arg-Trp-.  
     
     
         45 . The method of claim  1 , wherein the therapeutically effective amount is sufficient to affect a biological activity selected from the group consisting of lipolysis and uptake of fatty acids by adipocytes in the animal.  
     
     
         46 . The method of claim  1 , further comprising administering to the animal a body weight regulating agent.  
     
     
         47 . The method of claim  13 , wherein the body weight regulating agent is leptin.  
     
     
         48 . The method of claim  14 , wherein the leptin is administered in a dose of between about 0.1 μg and about 100 mg per day per kg of body weight of the animal.  
     
     
         49 . The method of claim  1 , further comprising administering an agent which inhibits the MSH compound from entering the central nervous system of the animal.  
     
     
         50 . The method of claim  17 , wherein the MSH compound does not activate the MC4-R receptors in the central nervous system.  
     
     
         51 . The method of claim  1  further comprising one or more of the following steps: measuring the decrease of body weight or the reduction of weight gain of the animal, administering to the animal a body weight regulating agent and administering an agent which inhibits the MSH compound from entering the central nervous system of the animal; 
 a. wherein the therapeutically effective amount is between about 0.1 μg and about 1 mg per day per kg of body weight of the animal, is insufficient to measurably change the appetite of the animal and is sufficient to affect a biological activity selected from the group consisting of lipolysis and uptake of fatty acids by adipocytes in the animal;    b. wherein the MSH compound is administered by a nasal, oral, topical, rectal, parenteral, subcutaneous, intradermal, intravenous, intraperitoneal, or an intramuscular route;    c. wherein the MSH compound comprises a sequence of the formula: X aa   5 -His-X aa   7 -Arg-XX aa   9 , wherein 
 X aa   5  is selected from the group consisting of Asp and Glu;  
 X aa   7  is selected from the group consisting of Phe and D-Phe; and  
 X aa   9  is selected from the group consisting of Trp and D-Trp; and.  
   d. wherein the MSH compound does not measurably activate the MC4-R receptors in the central nervous system.    
     
     
         52 . A method of decreasing body weight or reducing the rate of weight gain in an animal, comprising the step of: 
 administering to the peripheral tissue of an animal a therapeutically effective amount of an μ-MSH agonist compound comprising a sequence of the formula: -His-Phe-Arg-Trp-, without administering the α-MSH agonist compound to the central nervous system of the animal.    
     
     
         53 . A method of decreasing body weight or reducing the rate of weight gain in an animal, comprising the step of: 
 administering to the peripheral tissue of an animal a therapeutically effective amount of α-MSH (SEQ ID NO:2), without administering the α-MSH compound of SEQ ID NO:2 to the central nervous system of the animal.