FDA Approves Eli Lilly’s Weight Loss Drug That Helped People Lose Up to 52 Pounds

The Food and Drug Administration on Wednesday has approved Zepbound, a new weight loss drug from drugmaker Eli Lilly that in clinical trials has been shown to help people lose up to 52 pounds in 16 months.

Related to Zep is the latest entrant in the field of powerful new drugs that already includes Novo Nordisk’s Ozempic and Wegovy and Lilly’s Mounjaro.

The FDA approved the drug for obese or overweight adults with at least one weight-related condition.

In a statement, Lilly said Zepbound should be available in the United States by the end of the year. Its list price will be around $1,060 for a month’s supply.

The cost could put the new drug out of reach for many people since insurance companies are often reluctant to cover weight-loss drugs and Medicare, by law, does not cover them.

“The current cost is too high for the general population,” said Dr. Nishant Shah, a preventive cardiologist at Duke University Medical Center in Durham, North Carolina. “We need to be able to reach patients in an affordable way.”

In the United States, 4 in 10 adults suffer from obesity, according to the Centers for Disease Control and Prevention.

Although the price of this drug is high, some analysts predict that it will become the best-selling drug in history.

Zepbound is part of a class of drugs called GLP-1 agonists, which mimic a hormone that helps reduce food intake and appetite. However, Zepbound also mimics a second hormone, called GIP, which, in addition to reducing appetite, may also improve how the body breaks down sugar and fat.

Zepbound shares the same active ingredient tirzepatide as Lilly’s popular diabetes drug Mounjaro.

In a Phase 3 clinical trial, Zepbound resulted in an average weight loss of 22.5% of body weight, or approximately 52 pounds, surpassing all weight loss medications currently on the market. Study participants had obesity or were overweight with at least one weight-related condition.

It is the most effective pharmaceutical form of obesity treatment ever devised, said Dr. Christopher McGowan, a gastroenterologist who runs a weight-loss clinic in Cary, North Carolina.

He added that the weight loss seen with the drug approximates the weight loss seen with bariatric surgery.

It’s a big problem, he said.

When it comes to whether a patient should choose between Lilly’s new drug and Wegovy, McGowan said the key factors to consider are insurance coverage and the patient’s individual response to each treatment.

When I talk to a patient, I’ll discuss both, he said.

However, like other drugs in its class, Zepbound carries a risk of gastrointestinal problems, including nausea, diarrhea, vomiting, constipation and stomach pain, according to the FDA.

The label does not specifically mention the risk of stomach paralysis, also called gastroparesis, a more serious complication reported by some patients as weight-loss drugs have gained popularity. (In August, Lilly and Novo Nordisk were sued over allegations that their blockbuster drugs Mounjaro and Ozempic caused stomach paralysis.)

Dr. Daniela Hurtado Andrade, an endocrinologist at the Mayo Clinic, said that although gastrointestinal problems are very common with GLP-1 medications, most side effects will not affect a person’s quality of life.

I’ve only had to stop the medication on very rare occasions, said Andrade, who prescribes Mounjaro off-label for weight loss. But the reality is that the majority of patients will be able to find a dose that does not cause significant side effects.

To lessen side effects, doctors recommend starting patients on a lower dose of the drug and gradually increasing it over a few weeks, she said.

Typically, we increase the dose every four weeks, she said. But I’ve had patients who had to stay on the lowest level for 12 weeks and then move up and stay on the second dose for another 12 weeks.

Alexis Mitchell, 30, from Charlotte, North Carolina, was overweight for most of her 20s. It wasn’t until last year, following a health issue related to high blood pressure and prediabetes, that her doctor recommended Mounjaro off-label for weight loss.

She started taking a weekly dose of 2.5 milligrams of Mounjaro and gradually increased it to 15 mg. She started seeing results immediately.

For me, it was a game changer,” Mitchell said. Like OK, you need to change your life now. For example, there are no more games.

She experienced common side effects, including nausea, constipation, migraines, stomach pain and body aches, but the benefits, she said, made the discomfort worth it.

For me, the weight loss 100 percent outweighs the side effects, she said. I lost 123 pounds in one year. I mean, I couldn’t have done it without Mounjaro.

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