“Eli Lilly’s Tirzepatide Confirmed to Aid Weight Loss in Clinical Study, Paving the Way for FDA Approval as Obesity Treatment”

The American pharmaceutical group Eli Lilly published on Thursday the results of a new clinical study confirming that its drug Tirzepatide, currently approved in the United States only against diabetes, helps with weight loss, reports AFP, quoted by Agerpres.

These results pave the way for possible approval of this drug in the near future by the Food and Drug Administration (FDA) for people suffering from obesity.

The study was conducted on a sample of over 900 overweight or obese participants diagnosed with type 2 diabetes (the most common type). The medicine is administered only once a week in the form of an injection.

People who received the highest dose lost an average of 15.6 kilograms (15.7% reduction in body weight) over a period of about a year and a half (72 weeks).

Side effects were generally gastrointestinal problems (nausea, diarrhea, vomiting).

The pharmaceutical company hopes to have the drug approved as an obesity treatment by the end of the year

Thanks to these results, Eli Lilly plans to finalize its application for approval of the drug for obese and overweight patients “in the coming weeks” and “expects a regulatory decision by the end of 2023.”

A first clinical study, the results of which were published in a scientific journal in June 2021 and which targeted obese and overweight people but did not suffer from diabetes, demonstrated an even more important 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.

The drug is marketed under the name Mounjaro for people with type 2 diabetes after an FDA approval in May 2022.

But certain American doctors are already prescribing it outside the marketing authorization, recommending it to people who want to lose weight, even though they don’t have diabetes.

In the United States, approximately 40% of adults are obese.

How many billions of dollars could the world market for obesity treatments grow to in the coming years

Treatments using GLP-1 analogues represent a real hope for many specialists, as they cause much more significant weight loss than the drugs available to date.

There is also considerable commercial stake for pharmaceutical companies: According to Morgan Stanley, the global market for obesity treatments could reach $54 billion by 2030.

The manufacturer Novo Nordisk is already marketing a new treatment of this type in the United States, called Wegovy and approved by the FDA against obesity in June 2021.

Its approved anti-diabetic counterpart, Ozempic, which uses the same molecule (semaglutide), has recently faced periodic stockouts after making headlines on social media for its weight-loss properties.

However, medical experts are concerned about the risk of people who are not clearly overweight using it to lose a few pounds.

In the United States, there is also a problem of access to these extremely expensive new drugs (about $1,000 per month), because they are rarely reimbursed by health insurance companies. At the same time, they must be taken long-term, otherwise the patient risks gaining weight again when the treatment is stopped.