Eli Lilly & Co. on Thursday said tirzepatide met all primary and key secondary outcomes in a final Phase 3 study in adults with type 2 diabetes and increased cardiovascular risk.
The Indianapolis drugmaker said tirzepatide led to superior A1C and body weight reductions from baseline across all three doses compared to titrated insulin glargine in the study, which was the largest and longest trial of its program to date and the fifth and final global registration study for the drug candidate.
Eli Lilly said the study program has now met regulatory submission requirements for evaluating cardiovascular risk, and it plans to submit a full registration package to regulatory authorities by the end of the year.
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