Everything to Know About the New Weight-Loss Drug

The FDA is expected to approve tirzepatide for weight loss this year. Clinical studies found that patients lost an average of 22.5% of their body weight from the drug. The drug is not expected to be affordable for most.

A drug currently approved to improve blood sugar regulation in adults with type 2 diabetes is expected to be approved by the Food and Drug Administration (FDA) for weight loss this year—and there are many concerns about who will be able to cope with it.

The drug, which is called tirzepatide (or its brand name Monjaro), could lead to up to $48 billion in annual sales and could become the most popular drug ever once approved, experts tell NBC News.

Its use is expected to expand to include weight loss treatment thanks to impressive findings in a phase 3 clinical trial. In the trial, researchers found that patients lost an average of 22.5% of their body weight (or about 52 pounds). By comparison, similar weight loss drugs Wegovy and Saxenda reduced body weight by about 15% (Wegovy) and 5% (Saxenda).

But what exactly is tirzepatide and how does it work? Here’s what you need to know.

What is tirzepatide?

Tirzepatide is in a class of medications called GLP-1 agonists, which mimic hormones involved in controlling blood sugar and appetite. It is given by injection once a week and has been shown to reduce the amount of food people eat and increase the amount of energy they burn, according to a press release from the drug’s maker Eli Lilly.

There are other GLP-1 agonists on the market — Wegovy and Saxenda — but tirzepatide has a hormone-mimicking element called GIP that can reduce appetite and improve how well your body breaks down sugar and fat, Eli Lilly explains. The drug’s components “work together to improve the way the brain sees weight, which leads to weight loss and better blood sugar regulation,” says Fatima Cody Stanford, MD, Ph.D., a physician at obesity medicine and clinical researcher at Massachusetts General Hospital. .

In phase 3 clinical trials, patients lost an average of 15 pounds more with tirzepatide than with a placebo and an average of 23 pounds more than the placebo group when using tirzepatide and insulin.

“Currently GLP-1 agonists are very popular for weight loss,” says Jamie Alan, Ph.D., associate professor of pharmacology and toxicology at Michigan State University. “It is predicted that this medicine will be much more useful.”

“This is another tool to help with weight loss,” says Mir Ali, MD, bariatric surgeon and medical director of MemorialCare Weight Loss Surgery Center at Orange Coast Medical Center in Fountain Valley, California. “But if it’s not used properly — with lifestyle modifications — eventually it won’t work.”

What is tirzepatide used for?

Tirzepatide is currently approved by the FDA to help improve blood sugar regulation in adults with type 2 diabetes as an adjunct to diet and exercise (as of May 2022). The drug specifically helps control blood sugar and is also injected under the skin once a week. The dose is adjusted as people meet their blood sugar goals, the FDA explains.

How much does tirzepatide cost?

So far, GoodRx says tirzepatide costs between $900 and about $1,200 for four pens without health insurance. However, the cost of the drug “will vary depending on insurance,” says Alan.

Stephanie Field, director of pharmacy operations at Corewell Health West, says type 2 diabetes patients who qualify for co-pay assistance through Eli Lilly can pay as little as $25 a month. However, this is for patients who are taking the drug for diabetes – not for weight loss.

Is it covered by insurance?

Right now, the drug is “only covered for patients with type 2 diabetes,” Field says, noting that “use for weight loss is considered off-label and not covered by the patient’s insurance.” (However, this may change once the drug receives FDA approval for weight loss.)

Once tirzepatide is approved by the FDA, Dr. Ali says it is “unlikely” to be accepted by most insurance companies. “If it is, it will be quite expensive for most patients,” he says. “Hopefully, that will change over time.”

Field says patients can expect the cost of tirzepatide for weight loss to be similar to that of other similar drugs on the market. “There are two GLP-1 medications with weight loss indications approved by the FDA — Saxenda and Wegovy,” says Field. “Cash prices for patients can vary depending on the pharmacy, but average around $1,000 for a month’s worth of medication.”

However, if you have a high level of insurance, Dr. Stanford says the drug could be more affordable. “If not, that would be a high cost,” she adds.

Who can afford tirzepatide?

It depends. “It depends on your insurance. It also depends on your personal finances and how important this treatment is to you,” says Alan. Once the drug is approved by the FDA, “some insurances may cover it for diabetes or pre-diabetes and not cover it for weight loss,” Alan says.

How safe is tirzepatide for weight loss?

Overall, the drug is “pretty safe,” says Alan. However, she adds, “we’ll know more as more people take this drug.” Currently, the FDA lists the possible side effects of tirzepatide as follows:

nausea vomiting diarrhea headache loss of appetite constipation upper abdominal discomfort and abdominal pain

Nausea is a common side effect, Alan points out, but tirzepatide is still generally considered a safe option. “Always talk to your doctor to see if this drug is safe for you,” says Alan.

Korin Miller is a freelance writer specializing in general wellness, sexual health and relationships, and lifestyle trends, with work appearing in Men’s Health, Women’s Health, Self, Glamor and more. She has a master’s degree from American University, lives by the beach, and hopes to own a pork teacup and taco truck one day.