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# Lilly Obesity Drug Gains FDA Approval
- URL: https://www.fdaweb.com/lilly-obesity-drug-gains-fda-approval/
- Published: 2023-11-08T12:00:00.000Z
- Updated: 2026-09-14T14:15:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155746

FDA has approved an Eli Lilly NDA for [Zepbound](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmFjY2Vzc2RhdGEuZmRhLmdvdi9kcnVnc2F0ZmRhX2RvY3MvbGFiZWwvMjAyMy8yMTc4MDZzMDAwbGJsLnBkZj91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjMxMTA4Ljg1MzUxNDExIn0.sJlohGnhiCwKSd9p8MXE0dWKpwS4TZKbNVgJGgNwvmk/s/1255931999/br/230338786478-l?ref=fdaweb.com) (tirzepatide) subcutaneous injection for chronic weight management in adults with obesity who are on a reduced calorie diet and an exercise regimen. Tirzepatide, which is already approved under the trade name Mounjaro for treating Type 2 diabetes, is intended for use in those who are obese (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (hypertension, Type 2 diabetes or high cholesterol).

 **“**Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake,” an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management?ref=fdaweb.com) says. Its effectiveness was demonstrated in two randomized, double-blind, placebo-controlled trials of adults with obesity or overweight.

The largest trial enrolled adults without diabetes. “In this trial, those randomized to receive the highest approved dosage of Zepbound (15 mg once weekly) lost on average 18% of their body weight compared to those randomized to placebo,” the agency says. Adults with Type 2 diabetes who took Zepbound 15 mg lost on average 12% of their body weight compared to those on placebo.

On the safety side, Zepbound is associated with side effects such as nausea, diarrhea, vomiting, constipation, stomach discomfort and pain, injection site reactions, fatigue, allergic reactions, burping, hair loss and gastroesophageal reflux disease, FDA says. “Zepbound causes thyroid C-cell tumors in rats. It is unknown whether Zepbound causes such tumors, including medullary thyroid cancer, in humans,” it adds. “Zepbound should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome Type 2.