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Abstract
The present invention relates to semaglutide for use in weight management.
Core Innovation
The document discloses administering semaglutide subcutaneously for reducing body weight of a subject in need thereof. The semaglutide regimen is characterized by an amount in a weekly dosing range and is positioned for chronic weight management, including treatment of obesity and overweight.
The document frames the problem as the need for improved body-weight loss while managing gastrointestinal adverse events, particularly nausea, during chronic weight management. It emphasizes an unexpectedly improved ratio of weight reduction to gastrointestinal safety risk at high doses and describes a defined safety profile that tracks nausea as a key adverse event.
The document includes dosing ranges and administration routes, describing semaglutide given by subcutaneous injection once weekly or once daily. It also describes target populations including human adults, adolescents, and children, with BMI thresholds for overweight and obesity and with or without type 2 diabetes mellitus.
Claims Coverage
The independent claim covers a semaglutide subcutaneous method for reducing body weight using a weekly amount range. Across the dependent claims, the inventive features are refined by specifying the administration frequency, target subject BMI categories, and the presence of weight-related comorbid conditions, including type 2 diabetes mellitus.
Weekly subcutaneous semaglutide dosing for body weight reduction
A method for reducing body weight of a subject in need thereof, comprising administering semaglutide subcutaneously to the subject in an amount of 2.0-10.0 mg weekly.
Once-weekly administration
The method further specifies that semaglutide is administered once weekly.
Treatment of overweight subjects
The method is applied to a subject who is overweight.
Treatment of obesity subjects
The method is used for a subject who suffers from obesity.
Selection using weight-related comorbid conditions
The method is applied to a subject who has at least one weight-related comorbid condition selected from hypertension, type 2 diabetes mellitus, dyslipidemia, sleep apnoea, and urine incontinence.
Presence of type 2 diabetes mellitus
The method is applicable when the subject has type 2 diabetes.
Overall, the claim set centers on reducing body weight by subcutaneously administering semaglutide with a weekly dose range, refined toward once-weekly dosing and specific target groups (overweight, obesity, and/or weight-related comorbidities), including explicit inclusion of subjects with type 2 diabetes mellitus.
Stated Advantages
Unexpectedly improved body-weight loss relative to gastrointestinal safety risk, emphasizing an improved ratio of weight reduction to gastrointestinal adverse events, especially nausea.
Relatively lower increase in gastrointestinal adverse events, especially nausea, at high doses.
Documented Applications
Chronic weight management/obesity treatment in human subjects, with emphasis on semaglutide dose-response effects on body weight change and associated gastrointestinal adverse events and nausea.
Clinical trial use cases are described for obese subjects without diabetes (52-week trial) comparing semaglutide dose-response versus liraglutide 3.0 mg and placebo.
Clinical trial use cases are described for subjects with type 2 diabetes mellitus (26-week trial) comparing semaglutide dose-response versus liraglutide and placebo.
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