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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.
Is Mounjaro® (tirzepatide) approved to reduce the risk of major adverse cardiovascular events (MACE)?
Tirzepatide is not approved to reduce the risk of major adverse cardiovascular events. An ongoing study (SURPASS-CVOT) will evaluate the cardiovascular outcomes of tirzepatide in patients with T2D.
See important safety information, including boxed warning, in the attached prescribing information.
Cardiovascular Outcomes
Tirzepatide is not indicated to reduce the risk of major adverse cardiovascular events (MACEs) in adults with type 2 diabetes (T2D).1
The ongoing study, SURPASS-CVOT (cardiovascular outcome trial) is currently evaluating the effect of tirzepatide versus dulaglutide on MACEs in people with T2D.2
Enclosed Prescribing Information
References
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
2A study of tirzepatide (LY3298176) compared with dulaglutide on major cardiovascular events in participants with type 2 diabetes (SURPASS-CVOT). ClinicalTrials.gov identifier: NCT04255433. Updated February 21, 2022. Accessed March 8, 2022. https://clinicaltrials.gov/ct2/show/NCT04255433
Date of Last Review: August 11, 2023