The US Food and Drug Administration approved the type 2 diabetes drug tirzepatide for use in chronic weight management Wednesday, making official the use of a medicine already widely prescribed off-label for weight loss.
The drug, called Mounjaro for diabetes, will be called Zepbound for weight loss, according to a news release from the FDA. Made by Eli Lilly, it’s part of a new class of drugs that includes semaglutide, known as Ozempic for diabetes and Wegovy for weight loss, which have skyrocketed in popularity in recent years.
Zepbound is the latest diabetes drug approved for weight loss, joining Novo Nordisk’s Wegovy, a high-dose version of its diabetes treatment Ozempic.
The FDA approved Lilly’s drug for people who are considered obese, with a body mass index of 30 or higher, or those who are overweight with a related health condition, like high blood pressure, high cholesterol or diabetes. The drug should be paired with a healthy diet and regular exercise, the FDA said.
Studies suggest it could lead to more dramatic weight loss than semaglutide.
Last month, a study found that tirzepatide helped some people with obesity or overweight lose about a quarter of their body weight -- when paired with an extensive diet and exercise program.
Novo’s Wegovy (like its sister diabetes drug Ozempic) targets receptors of the GLP-1 hormone, and has shown in trials to cut around 15% of people’s body weight. Meanwhile, Zepbound, which targets both the GLP-1 and GIP hormones, has shown up to 21% weight loss in trials.
The most common side effects for both medicines include nausea, diarrhea, and vomiting. Both treatments have a boxed warning for the potential risk of thyroid C-cell tumors.
The drugs tirzepatide in Zepbound and Mounjaro and semaglutide in Wegovy and Ozempic work by mimicking hormones that kick in after people eat to regulate appetite and the feeling of fullness. Both imitate a hormone called glucagon-like peptide-1, known as GLP-1. Tirzepatide targets a second hormone, called glucose-dependent insulinotropic polypeptide, or GIP.
Tirzepatide, the active ingredient in Zepbound, has already been approved by the FDA and marketed as Mounjaro, a weekly diabetes drug injection that controls blood sugar. Zepbound is a GLP-1 (glucagon-like peptide-1) receptor agonist that activates hormone receptors that reduce appetite and food intake, and mimics the GIP (glucose-dependent insulinotropic polypeptide) hormone that helps release insulin, which controls blood sugar levels after eating. Around 70% of adults in America are obese or overweight, the FDA said, noting many overweight adults have a weight-related condition such as high blood pressure or Type 2 diabetes. Using diet and exercise to reduce five to 10% of body weight can lead to a reduced risk of cardiovascular disease in obese or overweight adults, the FDA said. Zepbound joins the ranks of other popular weight loss drugs such as Mounjaro and Novo Nordisk’s Ozempic and Wegovy, which are facing shortages.
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