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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Ser. No. 61 / 711,413, filed Oct. 9, 2012, the contents of which are incorporated by reference in their entirety into the current disclosure.[0002]Obesity is a life-threatening disorder in which there is an increased risk of morbidity and mortality arising from concomitant diseases such as type II diabetes, hypertension, stroke, cancer and gallbladder disease.[0003]Obesity is now a major healthcare issue in the Western World and increasingly in some third world countries. The increase in numbers of obese people is due largely to the increasing preference for high fat content foods but also the decrease in activity in most people's lives. Currently about 30% of the population of the USA is now considered obese.[0004]Whether someone is classified as overweight or obese is generally determined on the basis of their body mass index (BMI) which is calculated by divid...

AI Technical Summary

Benefits of technology

The patent text discusses the need for a safe and effective treatment for obesity and related disorders. The text highlights the role of the 5-HT2C receptor in regulating eating behavior and reducing body weight. The text describes the development and clinical trial results of lorcaserin, a selective 5-HT2C agonist. The data shows that lorcaserin consistently produced significant weight loss with excellent tolerability and improved quality of life. The technical effect of the invention is to provide a new treatment option for obesity and related disorders that targets the 5-HT2C receptor to safely decrease food intake and body weight.

Problems solved by technology

Obesity is a life-threatening disorder in which there is an increased risk of morbidity and mortality arising from concomitant diseases such as type II diabetes, hypertension, stroke, cancer and gallbladder disease.

As the BMI increases there is an increased risk of death from a variety of causes that are independent of other risk factors.

There are problems however with the BMT definition in that it does not take into account the proportion of body mass that is muscle in relation to fat (adipose tissue).

Obesity considerably increases the risk of developing cardiovascular diseases as well.

Kidney disease, also called nephropathy, occurs when the kidney's “filter mechanism” is damaged and protein leaks into urine in excessive amounts and eventually the kidney fails.

Diabetes is also a leading cause of damage to the retina at the back of the eye and increases risk of cataracts and glaucoma.

Finally, diabetes is associated with nerve damage, especially in the legs and feet, which interferes with the ability to sense pain and contributes to serious infections.

However, many patients find this difficult and need additional help from drug therapy to maintain results from these efforts.

Most currently marketed products have been unsuccessful as treatments for obesity because of a lack of efficacy or unacceptable side-effect profiles.

However, side effects associated with these products may limit their long-term utility.

Also, 5-HT2C knockout mice are overweight with cognitive impairment and susceptibility to seizure.

In addition, heart rate and blood pressure went down.

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