US FDA
FDA approved Zepbound, containing tirzepatide, for chronic weight management in adults with obesity or overweight with at least one weight-related condition.
The FDA's November 8, 2023 news release announced approval of Zepbound (tirzepatide) injection for chronic weight management in adults with obesity, or overweight with at least one weight-related condition, alongside reduced-calorie diet and increased physical activity. The release ties the approval to two randomized, double-blind, placebo-controlled 72-week trials, reports average body-weight reductions at the highest approved dose in adults without diabetes and adults with type 2 diabetes, and lists major safety warnings and common adverse effects.
approved Zepbound (tirzepatide) injection for chronic weight management
FDA describes Zepbound as tirzepatide injection for chronic weight management in adults with obesity, or adults with overweight and at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. The approval is described in addition to reduced-calorie diet and increased physical activity.
The release notes that tirzepatide was already approved as Mounjaro for use with diet and exercise to improve blood sugar in adults with type 2 diabetes mellitus.
FDA describes Zepbound as activating GLP-1 and GIP hormone receptors to reduce appetite and food intake.
FDA says effectiveness was established in two randomized, double-blind, placebo-controlled trials in adults with obesity or overweight with at least one weight-related condition. The release reports 2,519 participants receiving Zepbound and 958 receiving placebo over 72 weeks.
In the larger trial in adults without diabetes, the release reports an average 18% body-weight reduction at the highest approved 15 mg once-weekly dose compared with placebo. In adults with type 2 diabetes, it reports an average 12% reduction at the same dose compared with placebo.
FDA lists common side effects including nausea, diarrhea, vomiting, constipation, abdominal discomfort or pain, injection-site reactions, fatigue, hypersensitivity reactions, burping, hair loss, and gastroesophageal reflux disease. The release also flags thyroid C-cell tumors in rats, medullary thyroid cancer and MEN2 contraindication language, pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, diabetic retinopathy, and suicidal behavior or thinking warnings.
The release states that Zepbound received Priority Review and Fast Track designations for this indication, and that FDA granted approval to Eli Lilly and Co.
FDA. FDA Approves New Medication for Chronic Weight Management 2023.
Accessed 2026-06-08.
FDA approval announcement for Zepbound, a tirzepatide product for chronic weight management in specified adults.