The U.S. Food and Drug Administration (FDA) has approved a new medication for chronic weight management in adults with obesity or overweight with weight-related medical problems. The medication, Zepbound (tirzepatide), is the first and only treatment of its kind that activates two hormones involved in regulating appetite and food intake.
Zepbound is a once-weekly injection that works by stimulating the receptors of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), two hormones secreted from the intestine that reduce hunger and increase satiety. Zepbound is indicated for adults with a body mass index (BMI) of 30 kg/m2 or greater, or a BMI of 27 kg/m2 or greater with at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol. Zepbound should be used in combination with a reduced-calorie diet and increased physical activity.
The approval of Zepbound was based on the results of two phase 3 clinical trials involving more than 3,500 participants with obesity or overweight with weight-related medical problems. In both trials, Zepbound demonstrated significant and sustained weight loss compared to placebo after 72 weeks of treatment. At the highest dose of 15 mg, Zepbound reduced body weight by an average of 48 pounds, or 21% of the initial weight, compared to 7 pounds, or 3%, with placebo. Additionally, Zepbound improved several cardiometabolic risk factors, such as blood pressure, cholesterol, and blood sugar levels.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, such as heart disease, stroke, and diabetes,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
Zepbound is manufactured by Eli Lilly and Company, a global pharmaceutical company based in Indianapolis, Indiana. Zepbound is expected to be available in pharmacies in early 2024. The most common side effects of Zepbound are nausea, diarrhea, vomiting, and constipation. Zepbound should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines, and it has not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis.
For more information about Zepbound, please visit the FDA website or the Lilly website.
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