FDA approves new version of diabetes drug Mounjaro for weight loss
Federal regulators say a new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug
A new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug, U.S. regulators announced Wednesday.
The U.S. Food and Drug Administration approved Eli Lilly's drug, named Zepbound. The drug, also known as tirzepatide, helped dieters lose as much as 40 to 60 pounds in testing.
Zepbound is the latest diabetes drug approved for chronic weight management, joining Novo Nordisk's Wegovy, a high-dose version of its diabetes treatment Ozempic. Both are weekly injections.
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 reduced-calorie diet and regular exercise, the FDA said.
In the U.S., at least 100 million adults and about 15 million children are considered obese.
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.
FDA’s approval was based on two large studies: More than 2,500 participants got different strengths of Zepbound and nearly 1,000 people got dummy shots over 16 months. Participants without diabetes who received the highest dose lost about 18% of their weight, or about 41 pounds (19 kilograms), compared to placebo. Those with diabetes, who have a harder time losing
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