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Mounjaro ® (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 Mounjaro® (tirzepatide) been studied in patients with polycystic ovary syndrome (PCOS)?
Lilly has not sponsored any clinical studies to evaluate the safety or efficacy of tirzepatide in patients with PCOS. Participants with PCOS were not explicitly excluded from tirzepatide clinical studies; however, there is no subgroup analysis.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide Use in Patients With Polycystic Ovary Syndrome
Eli Lilly and Company has not sponsored a study to evaluate the safety and efficacy of tirzepatide in people with polycystic ovary syndrome (PCOS).
However, participants with polycystic ovaries were not explicitly excluded from the tirzepatide phase 3 clinical trial programs in type 2 diabetes (T2D).1-5
No subgroup analyses have been conducted in participants with PCOS in these studies.
Preexisting Polycystic Ovary Syndrome in Tirzepatide Type 2 Diabetes Studies
In the tirzepatide T2D studies, the percentage of female participants with a preexisting condition of PCOS at baseline was
- 1.3% in SURPASS-1
- 1.0% in SURPASS-2
- 0.8% in SURPASS-3
- 0.1% in SURPASS-4, and
- 0.9% in SURPASS-5.6
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6
2Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519
3Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. https://doi.org/10.1016/S0140-6736(21)01443-4
4Del Prato S, Kahn SE, Pavo I, et al; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. https://doi.org/10.1016/S0140-6736(21)02188-7
5Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. https://doi.org/10.1001/jama.2022.0078
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: May 01, 2025