FDA Approves Semaglutide As An Powerful Weight-loss Drug
Release date：2021/6/7 9:52:42
According to statistics from the World Health Organization (WHO), nearly 2 billion people are overweight or obese in the world. From 1975 to 2016, the global obesity rate has nearly tripled. Every year, overweight or obesity causes 2.8 million deaths.
In fact, obesity is not only a feature, but also a disease. Obese people not only have inconvenience in life and decreased exercise capacity, but are also more susceptible to metabolic diseases, cardiovascular and cerebrovascular diseases. In addition, many studies have shown that obesity is associated with more than ten kinds of cancers. The increased risk of disease is related to the decrease of prognosis and survival rate.
Therefore, more and more people start to lose weight based on health or beauty considerations. The most effective way to lose weight is exercise + dieting, but most people who want to lose weight find it difficult to stick to it. Therefore, many people hope to achieve rapid weight loss through drugs. However, the current weight loss drug market either has poor results or obvious negative effects.
But this situation has been changed now. On June 4, the FDA approved Novo Nordisk's semaglutide as a weight-loss drug under the trade name wegovy. Semaglutide has an outstanding weight-loss effect and is evaluated as the first time that humans have achieved weight-loss effects that could only be achieved by surgery before using drugs.
The drug was originally used to treat diabetes. It is a structural analogue of human glucagon-like peptide 1 (GLP-1), which can mimic its effect, reduce hunger, reduce diet, and reduce calorie intake. Therefore, the effect is outstanding in terms of weight loss. The results of the phase 3 clinical trial showed that participants lost an average of 15.3 kg in weight.
What is the weight loss effect of semaglutide? Let's take a look at the results of its phase 3 clinical trial.
On February 10, 2021, the top international medical journal New England Journal of Medicine (NEJM) published a global large-scale clinical trial led by a research team from University College London (UCL), involving 1961 people in 16 countries around the world. The results of the trial showed the new weight-loss drug semaglutide has an outstanding effect. Participants in this clinical trial lost an average of 15.3 kg.
Specifically, three-quarters of people lose more than 10% of their weight, and more than one-third lose more than 20% of their weight. This weight-loss effect can be called a "game-changing", and it is also the first time that humans have achieved weight-loss effects that could only be achieved by surgery before using drugs.
More importantly, people who lose weight after taking the new weight loss drug semaglutide have reduced risk factors for heart disease and diabetes such as waist circumference, blood lipids, blood sugar, and blood pressure, and their overall quality of life has also been improved.
Semaglutide is a structural analogue of human glucagon-like peptide 1 (GLP-1) that can mimic its effects and has been approved for the treatment of type 2 diabetes. Because semaglutide can reduce hunger, reduce diet, and reduce calorie intake, it is considered to be used to treat obesity.
This clinical trial called the therapeutic effect of semaglutide in obese patients has passed phase 1 and phase 2 clinical trials, but the safety of the 2.4 mg dose still needs to be evaluated.
This three-phase randomized controlled clinical trial involves 1961 overweight or obese adults (none of them suffering from diabetes, average weight 105 kg, average body mass index 38 kg/m2), the clinical trial was conducted at 129 sites in 16 countries in Asia, Europe, and North and South America.
Participants received a subcutaneous injection of 2.4 mg of semaglutide (or placebo) per week, which is similar to the way that diabetic patients inject insulin. Overall, 94.3% of the participants completed the 68-week study beginning in the fall of 2018. Participants received face-to-face or telephone consultation and guidance from a registered dietitian every four weeks.
Patients treated with semaglutide lost an average weight of 15.3 kg, and their average body mass index (BMI) dropped by 5.54. The average weight loss of the placebo group was 2.6 kg, and the average BMI decreased by 0.92.
More importantly, people who lose weight after using semaglutide have reduced risk factors for heart disease and diabetes such as waist circumference, blood lipids, blood sugar, and blood pressure, and their overall quality of life has also been improved.
In this phase 3 clinical trial, some participants reported side effects, including mild to moderate nausea and diarrhea, but these side effects are short-lived and can usually be resolved without the need to terminate the trial permanently.
This clinical trial represents a major advance in the treatment of obesity, because semaglutide has been approved to treat type 2 diabetes in low doses, so doctors are already familiar with its usage. With the results of this large-scale clinical trial as evidence, semaglutide was approved by the FDA for marketing less than four months after the release of the phase 3 clinical results.
As a reliable PEG supplier, Biochempeg continuously expands its capability to provide large-scale manufacture of high purity monodisperse PEG derivatives with an extensive variety of functional groups, in both non-GMP and GMP grade. We supply four kind of semaglutide intermediates, they are Fmoc-NH-PEG2-CH2COOH(CAS NO.166108-71-0), NH2-PEG2-CH2COOH(CAS NO.134978-97-5), Boc-NH-PEG2-CH2COOH(CAS NO.108466-89-3) and CH2COOH-PEG2-NH2.HCl(CAS NO.134979-01-4).
 FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014
 Once-Weekly Semaglutide in Adults with Overweight or Obesity
Semaglutide Brings Breakthroughs In Weight Management For Type 2 Diabetes