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# Lilly Planning Tirzepatide Submission Soon
- URL: https://www.fdaweb.com/lilly-planning-tirzepatide-submission-soon/
- Published: 2023-04-27T12:00:00.000Z
- Updated: 2026-09-14T18:28:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154310

Eli Lilly says that following positive results from the Phase 3 SURMOUNT-2 trial, it plans to complete in coming weeks an FDA submission for its tirzepatide in adults with obesity or overweight with weight-related comorbidities. A company [statement](https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-achieved-157-weight-loss-adults-obesity-or?ref=fdaweb.com) says tirzepatide achieved up to 15.7% weight loss in adults with obesity or overweight and Type 2 diabetes in SURMOUNT-2 compared to placebo. The notice says the study met all co-primary objectives and all key secondary objectives.

Tirzepatide is described as a once-weekly glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide 1 receptor agonist. It is in Phase 3 development for adults with obesity, or overweight with weight-related comorbidity. It also is being studied as a potential treatment for people with obesity and/or overweight with heart failure with preserved ejection fraction, obstructive sleep apnea, and non-alcoholic steatohepatitis. Studies of the drug in chronic kidney disease and in morbidity/mortality in obesity are also ongoing, Lilly says.

FDA approved tirzepatide as Mounjaro on 5/13/22, indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.