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On November 8, 2023, the U.S. FDA approved tirzepatide, the first agonist of both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, for treating obesity in patients without diabetes. For this indication, tirzepatide will be branded as Zepbound. Tirzepatide previously has been approved for treating patients with type 2 diabetes, under the brand name Mounjaro.
Approval of tirzepatide for obesity was based on two large, randomized trials. In a trial published in 2022, 2500 adults with obesity but without diabetes were randomized to subcutaneous tirzepatide (5, 10, or 15 mg weekly) or placebo (NEJM JW Gen Med Aug 1 2023 and N Engl J Med 2022; 387:205). In the second trial, published in 2023, 900 ad…