First safe weight loss drug approved in U.S.

January 18, 2023  14:51

The U.S. has approved the world's first safe and effective obesity drug for adults and adolescents. The drug, called semaglutide, has been in development for 30 years. Clinical trials were conducted in eight countries, including Russia, reports RIA Novosti.

It used to be believed that people who were overweight simply lacked willpower to lose weight. This perception was changed in the mid-1990s, when the gene encoding the hormone leptin was discovered, which is produced by adipose tissue and causes a feeling of fullness. Laboratory mice with mutations in this gene had an inordinate appetite and quickly became fat. Adding leptin to the food reduced the feeling of hunger and the animals lost weight.

It is also known that the pancreatic insulin-stimulating and sugar-reducing hormones incretins, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), are among the factors that determine body mass.

Scientists have concluded that the main cause of obesity is a disorder of specific physiological processes. Which means it is a disease and can be treated.

The U.S. FDA began approving drugs for the treatment of type 2 diabetes that mimic the effects of the hormone GLP-1. Study participants were losing weight because of the effects of GLP-1 on the receptors that regulate appetite and slow down digestion. After that pharmaceutical companies decided to check whether drugs for diabetes could be used for weight loss, but they were not highly effective.

In early 2021, the Danish company Novo Nordisk reported the successful completion of phase III clinical trials of a new substance for the treatment of obesity, semaglutide. Those who received weekly injections lost an average of 14.9 percent of body weight after 16 months. In addition, the drug has virtually no side effects.

The drug also mimics the action of the hormone GLP-1, but it has, first, continued action, which means far fewer side effects, and second, better access to the appetite-regulating areas of the brain.

But the real revolutionary breakthrough in pharmacology was the FDA approval of semaglutide for the treatment of obesity in adolescents 12 years and older.

Results from Novo Nordisk's clinical trials showed that when injected weekly for 16 months, more than a third of adolescents had at least a 20 percent reduction in body weight. Blood sugar and low-density cholesterol levels were normalized and cardiovascular outcomes improved.

Importantly, 79 percent of semaglutide recipients experienced side effects - gastrointestinal distress, lower blood pressure, rashes and itching. But the severity of symptoms was generally lower than from previous drugs.

Drug developers can't yet say how sustainable the results achieved after treatment with semaglutide will be: most participants gained about two-thirds of the weight they lost after a year. The drug may have to be taken for life. This is now the most important question, given that a one-month course of injections costs more than $1,300, and the cumulative effect of even small side effects has not yet been evaluated.

Nevertheless, according to a press release, Novo Nordisk plans to launch mass production of semaglutide in the very near future.

Now the attention of scientists is focused on a potentially even more effective and safer drug, tirzepatide. This is the first drug that simultaneously activates GLP-1 and GIP receptors, which leads to improved blood sugar control. In May 2022 the remedy was approved for the treatment of type 2 diabetes in the USA, and in autumn of the same year - in the European Union, Canada, and Australia.

The results of Phase 3a clinical studies conducted by American company Eli Lilly, which developed the drug, showed: after six months, during which patients received weekly subcutaneous injections, their body weight decreased by an average of 21 percent. And in some cases - by 30 and more, and kept at this level for one to two years. Previously, such an effect had been achieved only with bariatric surgery.

After Phase 3b trials, which should be completed in April 2023, the company plans to apply for the use of tirzepatide for the treatment of obesity.

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