Methods for treating visceral fat conditions
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Publication Number
US-11324741-B2
Publication Date
2022-05-10
Expiration Date
Abstract
Disclosed are methods and compositions for treating visceral fat conditions and/or metabolic syndrome using combinations of naltrexone and bupropion.
Core Innovation
The invention relates to treating visceral fat conditions and metabolic syndrome by administering naltrexone and bupropion to a person identified or diagnosed as being in need thereof. The approach is directed to improving insulin resistance markers and metabolic parameters, with patient identification linked to visceral fat measures and metabolic syndrome criteria including waist-to-hip ratio and findings from computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound, as well as intra-abdominal fat area.
The disclosed regimen administers naltrexone or a pharmaceutically acceptable salt and bupropion or a pharmaceutically acceptable salt at daily dose ranges. The patent describes co-administration in a single dosage form and sustained-release formulations, including a specific example dose combination Bup+Nal 32/400.
Trial results from double-blind, placebo-controlled studies show greater improvements in insulin resistance marker(s) than expected from weight loss alone. The patent further describes dose-related visceral fat loss and statistically significant metabolic improvements for the combination dose Bup+Nal 32/400, with post-hoc analysis showing a higher proportion of subjects no longer meeting metabolic syndrome criteria and improved triglycerides/HDL/waist measures.
Claims Coverage
The content includes three independent claims covering improving insulin resistance markers, improving fasting blood glucose levels, and improving triglyceride levels or high-density cholesterol levels. Each independent claim is tied to the same naltrexone plus bupropion daily dose ranges and includes comparative efficacy against weight loss alone or against naltrexone or bupropion alone.
Improving markers of insulin resistance
Administering to a person in need thereof naltrexone or a pharmaceutically acceptable salt in about 4 mg to about 50 mg each day and bupropion or a pharmaceutically acceptable salt in about 100 mg to about 600 mg each day, wherein the improvement in markers of insulin resistance is greater than expected from weight loss alone.
Improving fasting blood glucose levels
Administering to a person in need thereof naltrexone or a pharmaceutically acceptable salt in about 4 mg to about 50 mg each day and bupropion or a pharmaceutically acceptable salt in about 100 mg to about 600 mg each day, wherein the improvement in fasting blood glucose is significantly greater than expected from naltrexone or bupropion alone.
Improving triglyceride levels or high-density cholesterol levels
Administering to a person in need thereof naltrexone or a pharmaceutically acceptable salt in about 4 mg to about 50 mg each day and bupropion or a pharmaceutically acceptable salt in about 100 mg to about 600 mg each day.
Across the independent claims, the core coverage is a regimen of naltrexone plus bupropion within stated daily dose ranges for improving insulin resistance markers, fasting blood glucose, and triglyceride/high-density cholesterol measures, with claim 1 and claim 5 requiring improvements that are greater than expected versus weight loss alone or versus either agent alone.
Stated Advantages
Improves markers of insulin resistance more than expected from weight loss alone.
Improves fasting blood glucose significantly more than expected from naltrexone or bupropion alone.
Improves triglyceride levels and/or high-density cholesterol levels.
Reduces visceral fat and improves metabolic parameters, including insulin resistance and lipid/glucose/metabolic parameters.
Reduces inflammation markers including IL-6 and CRP.
Reduces metabolic syndrome prevalence and cardiovascular risk.
A higher proportion of subjects no longer meet metabolic syndrome criteria for the 32/400 dose, with improved triglycerides/HDL/waist measures.
Documented Applications
Treating visceral fat conditions and metabolic syndrome in a person identified or diagnosed as being in need thereof.
Improving markers of insulin resistance, including by addressing visceral fat measures and metabolic syndrome criteria.
Improving fasting blood glucose levels.
Improving triglyceride levels or high-density cholesterol levels.
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