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Last year, the drugmaker submitted an application for approving tirzepatide for the treatment of HFpEF and obesity to the European Medicines Agency (EMA) and plans to submit it to other regulatory agencies soon.
[53] In two of these (NCT03954834 and NCT04039503), participants were randomly assigned to receive either tirzepatide or placebo injection weekly
The legal status of peptides and their regulatory framework also reflects this safety distinction, as approved GLP-1 medications like tirzepatide have undergone extensive clinical testing for both efficacy and safety
