Methods for treating visceral fat conditions

a technology for visceral fat and conditions, applied in the direction of biocide, drug composition, metabolic disorder, etc., can solve the problems the presence of visceral fat and its health consequences, so as to reduce the high-density lipoprotein (hdl) cholesterol level, increase and reduce the risk and/or severity

Inactive Publication Date: 2015-04-30
OREXIGEN THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

In any case, visceral fat and its health consequences can be present.
In any case, visceral fat and its health consequences can be present.

Method used

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  • Methods for treating visceral fat conditions

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example 1

[0039]A double-blind, placebo-controlled multi-center trial was conducted with 285 healthy, non-diabetic, obese subjects. The subjects were administered either bupropion 200 mg bid, placebo (P), naltrexone 48 mg qd (N1), or bupropion 400 mg with naltrexone 32 mg qd (BN2). 182 subjects completed 24 weeks of treatment. A subset of 60 subjects had dual energy X-ray absorptometry (DEXA) and multislice CT scans to measure body fat, lean tissue and visceral fat (American Diabetes Association Annual Meeting 2007).

[0040]The groups were matched at baseline. Markers of insulin resistance improved more with BN2 than expected from the weight loss alone. A robust effect on decreasing visceral fat was also evident.

TABLE 1Naltrexone &BupropionPlaceboNaltrexone 48 mgBupropion 400 mg32 / 400 mgWeight (%) −1.1 ± 0.6***−1.74 ± 0.9*** −3.14 ± 0.7***−7.1 ± 0.7Waist (cm)−1.0 ± 5.4**−3.8 ± 12.7 −2.9 ± 6.0−5.4 ± 7.6Fasting Glucose1.9 ± 1.3*3.4 ± 1.7* 3.5 ± 1.5*−2.0 ± 1.5(mg / dL)Insulin 0.9 ± 0.9** 1.7 ± 1.3**...

example 2

[0041]Subjects (n=117) received one of six treatments: two placebos (P+P), placebo and naltrexone (P+Nal), bupropion and placebo (Bup+P), bupropion and naltrexone 48 mg (Bup+Nal 48), bupropion and naltrexone 32 mg (Bup+Nal 32), or bupropion and naltrexone 16 mg (Bup+Nal 16).

[0042]Subjects had a DEXA body scan to measure total body fat, lean tissue and bone mineral content at baseline and at 6 months. Subjects also had a multi-slice CT scan to determine visceral fat volume at the same time points. The mass of selective visceral loss can be calculated based on total fat and the volume of visceral fat.

[0043]The average change in visceral body mass is shown in FIG. 1 for the four treatments. Patients receiving Bup+Nal 32 experienced a dose-related loss in visceral body mass. Statistically significant improvements were also observed in several important metabolic parameters including: plasma glucose, serum insulin and plasma triglycerides.

TABLE 2Baseline Weight, BMI and Weight Circumfere...

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Abstract

Disclosed are methods and compositions for treating visceral fat conditions and / or metabolic syndrome using combinations of naltrexone and bupropion.

Description

RELATED APPLICATION INFORMATION[0001]The present application is a continuation of U.S. application Ser. No. 12 / 995,121, filed Feb. 28, 2011, which is the U.S. National Phase under 35 U.S.C. §371 of International Application No. PCT / US2009 / 045720, entitled “METHODS FOR TREATING VISCERAL FAT CONDITIONS,” filed May 29, 2009, and published in English on Dec. 30, 2009 as WO2009 / 158114 A1, which claims the benefit of priority to U.S. Provisional Application No. 61 / 057,743, filed May 30, 2008, all of which are hereby incorporated by reference in their entireties. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]Embodiments of the present invention relate to methods and compositions for reducing visceral fat and / or treating metabolic syndrome....

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/485A61K31/137
CPCA61K31/137A61K31/485A61P1/02A61P29/00A61P3/00A61P3/04A61P35/00A61P3/06A61P43/00A61P9/00A61P9/10A61P9/12A61P3/10A61K2300/00
Inventor TOLLEFSON, GARY D.
Owner OREXIGEN THERAPEUTICS INC
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