Tirzepatide drug fast-tracked for weight loss indication by FDA: What to know

Tirzepatide, an injection medication already approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes, is likely to receive FDA approval for another indication — weight loss — later this year, according to multiple reports.

The medication from Eli Lilly has the potential to become a “blockbuster” weight-loss drug, according to reports. Yet experts caution that many patients may not be able to afford it.

“Tirzepatide is currently FDA-approved for treating Type 2 diabetes, but it is being fast-tracked through the FDA to receive an indication for the treatment of obesity,” Dr. Fatima Stanford of Boston told Fox News Digital. 

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Stanford is an obesity medicine specialist and an associate professor of medicine and pediatrics at Harvard Medical School. 

She also works in the endocrine division at Massachusetts General Hospital.

A medication called tirzepatide has the potential to become a “blockbuster” weight-loss drug, according to reports. Yet experts caution that many patients may not be able to afford it.
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Here’s a deeper look at some of the issues around this drug and its potential. 

What’s the definition of obesity and overweight?

To diagnose obesity, many health care providers use the Body Mass Index screening tool.

“If your BMI is 25.0 to <30, it falls within the overweight range," according to the Centers for Disease Control and Prevention (CDC). 

“If your BMI is 30.0 or higher, it falls within the obesity range.”

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Approximately 70% of American adults have obesity or are overweight, the FDA says.

These conditions are associated with several leading causes of death, including heart disease, stroke and diabetes.

How do current weight-loss medications work?

The body normally releases two hormones, GLP-1 (glucagon-like peptide) and GIP (glucose-dependent insulinotropic polypeptide), to stimulate the pancreas to release insulin, according to reports.

A current class of weight-loss medications on the market have been trending on TikTok after users discovered celebrities like Elon Musk and Andy Cohen highlighting their success with them. 

The feeling of being full sooner — also known as early satiety — leads people to eat less and potentially to lose a lot of weight.
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They are known as GLP-1 receptor agonists, which work by binding to receptors in the body to stimulate the pancreas to produce insulin. This mimics the effects of what the hormone GLP-1 does in the body, according to the University of Utah health’s website. 

Victoza, Ozempic and Trulicity are some of the brand names that are GLP-1 receptor agonists and initially developed for the treatment of diabetes, the website added.

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When people start eating, that stimulates the release of insulin for better blood sugar control.

Tirzepatide may be more effective because it binds to two receptors that decrease the sense of hunger — compared to only one receptor for current weight-loss medications.

But while the drugs regulate blood sugar levels, researchers found that the drugs also simultaneously cross the receptors in the brain to signal to people that they’re full, per the University of Utah Health’s website. 

This feeling of being full sooner — also known as early satiety — leads people to eat less and potentially to lose a lot of weight.

How does tirzepatide work?

Tirzepatide “is a dual agonist, including a GLP-1 agonist and a GIP, which helps regulate blood sugar and weight,” Dr. Stanford said. 

It may be more effective than current weight-loss medications because it binds to two receptors that decrease the sense of hunger, compared to only one receptor, such as those highlighted on social media platforms.

A young female talks with her doctor. The side effect profile of tirzepatide, an Eli Lilly drug, was similar to other therapies approved for the treatment of obesity that reduced blood sugars. The most common adverse effects were gastrointestinal-related, including nausea, vomiting, diarrhea and constipation. 
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Tirzepatide is FDA-approved under the brand name Mounjaro to improve blood sugar control for adults with Type 2 diabetes, according to an FDA press release sent out this past May. 

The drug is administered as an injection under the skin once a week. 

Eli Lilly hoped to expand its use by performing a double-blind randomized clinical trial known as SURMOUNT-1; it sought to compare the effectiveness and safety of tirzepatide to a placebo.

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“Participants taking tirzepatide lost up to 52 lb. (24 kg) in this 72-week phase 3 study,” the press release said last year.

Part of the reason more patients are not receiving these obesity medications is that their health insurance is not covering these drugs for weight loss, said one medical professional.

Among the…