Brand-new weight loss use could be approved for this drug

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New data released Thursday by Eli Lilly and Company showed that tirzepatide, the main ingredient in its Mounjaro prescription medicine, “achieved superior weight loss compared to placebo at 72 weeks of treatment.”

So, what does that mean? Experts say it could be the next major weight loss drug to hit the market, and one that has even better results than drugs like Ozempic.

The new drug is named Tirzepatide and marketed as Mounjaro for diabetics. Participants in a study lost about 21% of their body weight, which experts say is unprecedented, and the company behind it is seeking FDA approval for use in chronic weight management.

These results were part of the SURMOUNT-2 study. Similar results were observed in the SURMOUNT-1 study, according to research published in the New England Journal of Medicine last summer.

Results from the most recent trial will be will be presented at the American Diabetes Association’s 83rd Scientific Sessions and submitted to a peer-reviewed journal. Based on the results, Eli Lilly “plans to complete the U.S. submission for tirzepatide in adults with obesity or overweight with weight-related comorbidities in the coming weeks,” and it expects regulatory action as early as later this year.

Mounjaro was approved last May by the U.S. Food and Drug Administration to “improve blood sugar control in adults with type 2 diabetes.”

However, it has also been sought-after for its weight loss results, along with other similar drugs called Ozempic and Wegovy, according to a February article in The Cut. These are all GLP-1 receptor agonists.

“Tirzepatide is a single molecule that activates the body’s receptors for GIP and GLP-1, which are natural incretin hormones,” Eli Lilly explained. “Both GIP and GLP-1 receptors are found in areas of the human brain important for appetite regulation. Tirzepatide has been shown to decrease food intake and modulate fat utilization.”

Muonjaro is taken as a weekly injection. According to Eli Lilly, the medication does have some potential side effects, including thyroid tumors.

“It is not known if Mounjaro can be used in people who have had inflammation of the pancreas (pancreatitis,” said Eli Lilly. “Mounjaro is not for use in people with type 1 diabetes. It is not known if Mounjaro is safe and effective for use in children under 18 years of age.”

A New York woman in her early 50s referred to by The Cut as “Anna” said that Mounjaro helped her lose weight.

“I’m now one of those people who’s just, like, not that hungry,” she said. “And I feel better than everyone.”

According to The Cut, “sales figures bear out that the GLP-1 drugs are going gangbusters,” and Komodo Health – a firm that tracks health-care data for 330 million patient files – noted there was an uptick of people without a history of diabetes receiving the drugs.

“Since Ozempic, Wegovy, and Mounjaro took off, pharmacies have struggled to keep them on hand and patients have struggled to find them,” said the outlet, which also reported that the FDA was “fast-tracking its investigation into tirzepatide, the active ingredient in Mounjaro, for weight management.”

“Obesity is a difficult-to-manage disease, and it’s even more difficult for people living with type 2 diabetes,” said Jeff Emmick, senior vice president, product development, Lilly. “The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes.”

Eli Lilly said tirzepatide is in phase 3 development for adults with obesity, or overweight with weight-related comorbidity. It is being studied as a potential treatment for people with obesity and/or overweight with heart failure with preserved ejection fraction (HFpEF), obstructive sleep apnea (OSA), and non-alcoholic steatohepatitis (NASH).

“Studies of tirzepatide in chronic kidney disease (CKD) and in morbidity/mortality in obesity (MMO) are also ongoing,” said the company.

Per the study results releases Thursday, those taking tirzepatide (10 mg and 15 mg) lost up to 15.7% of body weight. The trial included 938 adult participants “with obesity or overweight and type 2 diabetes.”

Eli Lilly also plans to continue monitoring the study results.

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