The American pharmaceutical group Eli Lilly published on Thursday the results of a new clinical trial that confirms that its molecule tirzepatide, for the moment approved in the United States only against diabetes, helps in weight loss.
These results pave the way for a possible future authorization of this drug by the American Food and Drug Administration (FDA) specifically for obese people.
The study was conducted in just over 900 participants who were overweight or obese and had type 2 diabetes (the most common). The drug is taken once a week in the form of an injection.
People who received the highest dose lost an average of 15.6 pounds (15.7% reduction in body mass) over approximately one and a half years (72 weeks).
The side effects used to be gastrointestinal problems (nausea, diarrhea, vomiting…).
A “regulatory action” of late 2023
With these results, Eli Lilly plans to finalize its app for overweight or obese patients “in the coming weeks,” and “expects regulatory action as early as the end of 2023.”
A first clinical trial, the results of which were published in a scientific journal in June 2021 and in which this time people who were obese or overweight but did not have diabetes participated, had shown even greater weight loss, of the order of 21%.
Tirzepatide mimics a gastrointestinal hormone (GLP-1) that activates receptors in the brain that play a role in appetite regulation.
It is already marketed under the name Mounjaro for people with type 2 diabetes, since FDA clearance in May 2022.
But some US doctors already prescribe it outside of its marketing authorization for people who want to lose weight, even if they don’t have diabetes.
a business matter
In the United States, approximately 40% of adults suffer from obesity.
Treatments with GLP-1 analogues represent a real hope for many specialists, since they achieve much greater weight loss than the drugs available up to now.
This is a huge business gamble for pharmaceutical companies: according to Morgan Stanley, the global market for obesity treatments could be worth $54 billion by 2030.
The Novo Nordisk laboratory is already marketing a new treatment of this type in the United States, called Wegovy, and authorized by the FDA against obesity since June 2021.
Its licensed diabetes counterpart, called Ozempic and using the same molecule (semaglutide), has experienced periodic stockouts recently, after it caused a stir on social media for its weight-loss properties.
Experts worry that people who aren’t obviously overweight are abusing it to lose a few pounds.
In the United States there is also a problem of access to these very expensive new drugs (around 1000 dollars a month), which are often not reimbursed by health insurance. They must be taken very long term, at the risk of regaining weight when treatment is stopped.
Source: BFM TV
