Method of weight management

Abstract

Provided are methods of determining if an individual is a responder to treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof. Also provided are methods for selecting an individual for treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof from a plurality of individuals in need of weight management. Also provided are methods for weight management in an individual in need thereof. Also provided are compounds, compositions, and kits for use in a method of weight management in an individual.

1 .- 93 . (canceled) 
     
     
         94 . A method of weight management for an individual in need thereof, comprising:
 treating the individual for 12 weeks with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, wherein the individual is administered a dose equivalent to 20 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride per day;   evaluating the individual for a response by week 12 of the treatment, wherein the response is weight loss; and   continuing said treatment if the individual has achieved at least 5% weight loss by week 12 of the treatment, or   discontinuing said treatment if the individual has not achieved at least 5% weight loss by week 12 of the treatment,   wherein, prior to beginning the treatment, the individual has an initial body mass index (BMI) of ≧27 kg/m 2 , and   wherein the pharmaceutical composition is administered orally to the individual.   
     
     
         95 . The method of  claim 94 , wherein the individual has an initial body mass index≧30 kg/m 2 . 
     
     
         96 . The method of  claim 94 , wherein weight management comprises weight loss. 
     
     
         97 . The method of  claim 94 , wherein weight management comprises maintenance of weight loss. 
     
     
         98 . The method of  claim 94 , wherein the method further comprises administering a reduced calorie diet to the individual. 
     
     
         99 . The method of  claim 94 , wherein the method further comprises prescribing or administering a program of regular exercise to the individual. 
     
     
         100 . The method of  claim 94 , wherein the individual is evaluated for weight loss at week 12 of the treatment. 
     
     
         101 . The method of  claim 94 , wherein the individual has at least one weight-related comorbid condition selected from: hypertension, dyslipidemia, and type 2 diabetes. 
     
     
         102 . The method of  claim 94 , wherein the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof is (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate. 
     
     
         103 . The method of  claim 94 , wherein the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof is administered in tablet. 
     
     
         104 . A method of treating obesity in an individual in need thereof, comprising:
 treating the individual for 12 weeks with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, wherein the individual is administered a dose equivalent to 20 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride per day;   evaluating the individual for a response by week 12 of the treatment, wherein the response is weight loss; and   continuing said treatment if the individual has achieved at least 5% weight loss by week 12 of the treatment, or   discontinuing said treatment if the individual has not achieved at least 5% weight loss by week 12 of the treatment,   wherein, prior to beginning the treatment, the individual has an initial body mass index (BMI) of ≧30 kg/m 2 , and   wherein the pharmaceutical composition is administered orally to the individual.   
     
     
         105 . The method of  claim 104 , wherein the method further comprises administering a reduced calorie diet to the individual. 
     
     
         106 . The method of  claim 104 , wherein the method further comprises prescribing or administering a program of regular exercise to the individual. 
     
     
         107 . The method of  claim 104 , wherein the individual is evaluated for weight loss at week 12 of the treatment. 
     
     
         108 . The method of  claim 104 , wherein the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof is (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate. 
     
     
         109 . The method of  claim 104 , wherein the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof is administered in tablet. 
     
     
         110 . A method of weight management for an individual in need thereof, comprising:
 treating the individual with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, wherein the individual is administered a dose equivalent to 20 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride per day;   evaluating the individual for a response at week 12 of the treatment, wherein the response is weight loss; and   discontinuing said treatment if the individual has not achieved at least 5% weight loss by week 12 of the treatment,   wherein, prior to beginning the treatment, the individual has an initial body mass index (BMI) of ≧27 kg/m 2 , and   wherein the pharmaceutical composition is administered orally to the individual.   
     
     
         111 . The method of  claim 110 , wherein the individual has an initial body mass index≧30 kg/m 2 . 
     
     
         112 . The method of  claim 110 , wherein weight management comprises weight loss. 
     
     
         113 . The method of  claim 110 , wherein weight management comprises maintenance of weight loss. 
     
     
         114 . The method of  claim 110 , wherein the method further comprises administering a reduced calorie diet to the individual. 
     
     
         115 . The method of  claim 110 , wherein the method further comprises prescribing or administering a program of regular exercise to the individual. 
     
     
         116 . The method of  claim 110 , wherein the individual has at least one weight-related comorbid condition selected from: hypertension, dyslipidemia, and type 2 diabetes. 
     
     
         117 . The method of  claim 110 , wherein the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof is (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate. 
     
     
         118 . The method of  claim 110 , wherein the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof is administered in tablet.