An obesity or obesity, is a recognized chronic disease. According to the definition of the German Obesity Society, obesity is an accumulation of fatty tissue in the human body that exceeds normal levels and belongs to the group of hormonal, nutritional and metabolic diseases. Obesity can lead to insulin resistance, high blood pressure or dyslipidemia, and is associated with secondary diseases such as type 2 diabetes, cardiovascular disease and non-alcoholic fatty liver disease. Among other things, the so-called body mass index (BMI for short) is used as a reference value - however, it should be noted that the BMI alone can pose problems in determining this, as factors such as muscle mass, water retention, age or gender are not taken into account. This value is calculated from the weight in kg divided by the height squared. Other causes can be found in genetic predisposition, unhealthy eating habits, lack of exercise or various diseases. Numerous individual factors, such as hormones, influence human weight and can lead to symptoms such as an unusually high accumulation of fat in the body, reduced performance or shortness of breath. Under certain circumstances, long-term obesity can increase the risk of secondary diseases and lead to a shortened life expectancy.
Use of medications for treatment:
Changing long-standing eating habits is not easy for many people, and drug treatments have shown high risk on several occasions in the past - amphetamines, fenfluramine and lorcaserin have been withdrawn from themarket because of this. In previous studies, so-called GLP-1 agonists and SGLT-2 inhibitors were able to reduce body weight in type 2 diabetics. Meanwhile, manufacturers are also testing this effect in non-diabetics. In this context, the antidiabetic drug liraglutide, manufactured by Novo Nordisk, has already received approval.
A study published in 2021 now examined a GLP-1 agonist semaglutide produced by the same manufacturer. While liraglutide is to be taken once daily, a once-weeklysubcutaneous injection (i.e. under the skin) is sufficient for semaglutide.
Manufacturer's study method:
This double-blind, randomized trial published in the New England Journal of Medicineincluded 1961 adults with a BMI of 30kg/m2 or more who did not have diabetes. Study participants from 129 sites in 16 countries (including Germany) recorded a mean BMI of 37.9kg/m2, mean body weight of 105.3kg, and mean waist circumference of 114.7cm. 43.7% of subjects had pre-diabetes and 75% had at least one concomitant disease. All participants were assigned in a 2 : 1 ratio to 68 weeks of treatment with either once weekly semaglutide at a dose of 2.4mg, or a placebo plus dietary intervention (i.e. dietary changes). This intervention consisted of 17 monthly individual counseling sessions. In addition, subjects were to achieve a caloric deficit of 500 calories per day and engage in at least 2.5 h of physical activity per week. The participants were to record their diet and exercise in a diary each day. The active ingredients were administered using a device called a pen (i.e., stick).
The primary endpoints were percentage change in body weight and a weight reduction of at least 5%
While liraglutide, which has already been tested, was able to reduce body weight by an average of 8.4kg (vs. 2.8kg for the placebo group) after 56 weeks of treatment in a study published in 2015 with a comparable group of patients, semaglutide reduced subjects' weight by an average of 15.3kg (vs. 2.6kg for the placebo group).
The semaglutide group achieved a weight loss of more than 5% in 86.4% of participants, compared to only 31.5% of the placebo group. According to the study results, more than 70% overall achieved a weight reduction of more than 10%. Of these, a reduction of 10% or more: 69.1% in the study group, 12.0% in the placebo group. At least 15% weight reduction: 50.5% in the study group, 4.9% in the placebo group. Waist circumference reduced by 13.54cm (placebo group: 4.13cm).
According to the study, this reduction in weight had a positive effect on cardiovascular risk factors, as of the patients with pre-diabetes, 84.1% achieved normal blood glucose levels - 47.8% in the placebo group. About 7.0% of participants on semaglutide completed the study before the end of 68 weeks.
The manufacturer, Novo Nordisk, applied to the US FDA (i.e. Food and Drug Administration or Food and Drug Administration) and EMA (i.e. European Medicines Agency) for an extension of approval for non-diabetics back in December 2020, and is now awaiting the potential positive response. Approval would potentially help many non-diabetics with weight loss.