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Ipsen filed a resubmission a few months later, which the FDA rejected in December 2022 and requested additional information regarding the data that the company had already provided

Across the subgroups of patients with different baseline cardiovascular conditions, mean age ranged from approximately 59 to 67 years, baseline BMI from 33.8 to 36.3 kg/m 2 , and baseline type 2 diabetes prevalence from 25.4% in aortic disease to 50.8% in heart failure, with broadly balanced matching across the individual subgroups (Table 2)

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CJC-1295 (DAC) has weak, surrogate-only human data

more common if paired with insulin or sulfonylureas