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Zepbound ® (tirzepatide) injection
2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 12.5 mg/ 15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Has Zepbound® (tirzepatide) been studied in patients with polycystic ovary syndrome (PCOS)?
Eli Lilly and Company has not sponsored any clinical studies to evaluate the safety or efficacy of tirzepatide in patients with PCOS.
See important safety information, including boxed warning, in the attached prescribing information.
Patients With Polycystic Ovary Syndrome
Eli Lilly and Company has not sponsored a study to evaluate the safety and efficacy of tirzepatide in patients with polycystic ovary syndrome (PCOS). However, patients with polycystic ovaries were not excluded from the phase 3 clinical development program.1
Subanalysis in these patients is not available due to the limited number of participants with PCOS. In completed, phase 3, placebo-controlled, Zepbound® clinical studies, polycystic ovaries was reported as a preexisting condition in
- 1.9% (34/2806) in the tirzepatide arms, and
- 2.3% (18/1250) in the placebo arms.1
Enclosed Prescribing Information
Reference
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: December 20, 2024