Method of weight management

a weight management and weight technology, applied in the field of life-threatening disorders, can solve the problems of increasing the risk of morbidity and mortality, increasing the risk of death from a variety of causes, and increasing the risk of obesity

Inactive Publication Date: 2015-10-22
ARENA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0026]selecting the individual for treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically ac...

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 al...

Method used

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Examples

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example 1

Phase 3 Studies

[0399]APD356-009 (“BLOOM”) was a 104-week, placebo controlled study that assessed the safety and efficacy of lorcaserin 10 mg BID in overweight and obese patients, with concurrent behavior modification. The primary efficacy objective during Year 1 was to evaluate weight loss; the primary objective during Year 2 was to assess the ability of lorcaserin to maintain body weight loss that was achieved during Year 1. At study start, each patient received randomized, double blind treatment assignments for Year 1 and for Year 2 (all patients were given a new randomization number for Year 2 to assure that patients and study personnel remained blinded to treatment assignments). All patients assigned to placebo during Year 1 (50% of randomized population) remained on placebo in Year 2. Patients assigned to lorcaserin during Year 1 were randomly assigned to stay on lorcaserin during Year 2 (⅔ of Year 1 lorcaserin patients) or to switch to placebo (⅓ of Year 1 lorcaserin patients)...

example 2

Identifying Responders Based on Early Weight Loss

[0402]An analysis of early weight loss was performed, at each visit after baseline through Week 24, as a predictor of ultimate weight loss success, as defined by achieving at least about 5% weight loss at 52 weeks, or at least about 10% weight loss at 52 weeks. The area under the curve (AUC) for the receiver operating characteristic (ROC) curve measures the balance between specificity and sensitivity by measuring how often a predictor (e.g., Week 12 or Week 24 percent weight loss) and a successful outcome (e.g., at least 5% or 10% weight loss at Week 52) are concordant.

[0403]At Week 12, the optimal thresholds were 4.6% and 5.9% weight loss for predicting at least 5% and at least 10% weight loss at Week 52. At Week 24, the optimal weight loss thresholds were 6.1% and 8.5%, respectively (Table 1 and Table 2). Non-diabetic patients who achieved at least 5% weight loss at Week 12, lost on average approximately 10.6 kilos (23 pounds) at We...

example 3

Week 52 Outcomes for Those Achieving at Least 5% Weight Loss at Week 12

[0406]In patients without type 2 diabetes mellitus (T2DM), proportions achieving ≧5% weight loss and weight loss at Week 52 for (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride salt hemihydrate (“drug”) and placebo patients were 47 vs. 23% and 5.8 vs. 2.5 kg, respectively (MITT-LOCF). Results in patients with T2DM were 38 vs. 16% and 4.7 vs. 1.9 kg, respectively. Proportions meeting the ≧5% weight loss at Week 12 criterion were 49.3% and 35.9% for drug patients without and with T2DM, respectively, and 22.6% and 11.5% for placebo patients. Week 52 weight loss in non-diabetic drug Week 12 responders was 10.6 kg (23 lbs), and 86% and 50% of patients achieved at least 5% and 10% weight loss. In diabetic drug Week 12 responders, results were 9.3 kg (20 lbs), 71%, and 36%.

[0407]Week 52 reductions in FPG and A1C in diabetic drug Week 12 responders were 29.3 mg / dL and 1.2%, and were 7.8 mg / dL and 0...

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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...

Claims

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Application Information

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IPC IPC(8): A61K31/55A61K45/06A61K31/137A61K49/00
CPCA61K31/55A61K31/137A61K45/06A61K49/0004C07D223/16A61P3/04A61P43/00A61P3/10A61K2300/00A61K9/20A61K9/0053A23L33/30A23V2002/00A61B5/0073A61B5/0537A61B5/055A61B5/107A61B5/4848A61B5/4869A61B5/4872A61B6/03A61B6/482A61B6/50A61B8/48A63B24/0075G09B19/003G09B19/0092
Inventor SANCHEZ, MATILDESHANAHAN, WILLIAM R.
Owner ARENA PHARMA
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