26 Petty, L
The latest FDA guidance focuses on the design of trials to demonstrate sustained weight reduction: "Weight reduction is defined herein as a long-term reduction in excess adiposity (body fat) with a goal of reduced morbidity and mortality
In addition, exogenous IGF-1 administration has been shown to reduce serum glucose levels [95, 143, 144], not only in healthy individuals [140, 145147], but also in those with insulin resistance [148, 149], type I [150152], and T2D [153155]
to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight that may help adults and children aged 12 years and older with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose excess body weight and keep the weight off Wegovy contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines It is not known if Wegovy is safe and effective for use: for the treatment of MASH in children under 18 years to reduce the risk of major cardiovascular events (death, heart attack, or stroke) in children under 18 years for the treatment of long-term weight loss in children under 12 years Important Safety Information Do not use Wegovy if: you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy Before using Wegovy , tell your healthcare provider if you have any other medical conditions, including if you: have or have had problems with your pancreas or kidneys have type 2 diabetes and a history of diabetic retinopathy have or have had depression, suicidal thoughts, or mental health issues are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation) are pregnant or plan to become pregnant
