- Eli Lilly and Co LLY has reported topline data from Phase 3 SURPASS-4 clinical trial evaluating tirzepatide in adults with type 2 diabetes and increased cardiovascular risk.
- Measuring the GLP-1 receptor agonist tirzepatide against titrated insulin glargine, Lilly reported that its program hit all primary and key secondary endpoints across three dosage levels.
- The primary endpoint was measured at 52 weeks, and many participants continued treatment beyond 52 weeks, some up to two years.
- It’s the fifth Phase 3 study Lilly has completed for the candidate, and now it plans to submit details to regulatory authorities later in 2021.
- Participants began the study with an average baseline A1C of 8.52%, and each of the treatment arms lowered the levels at a significant rate compared to titrated insulin glargine, Lilly said.
- At one year, the changes for each escalating dose were -2.24%, -2.43% and -2.58%, against -1.44% for the control.
- Tirzepatide reduced weight from the average baseline by 8.1%, 10.7%, and 13% for the three arms, respectively.
- Meanwhile, participants in the titrated insulin glargine arm saw a mean weight increase of 2.2% relative to the baseline.
- Lilly noted that the overall safety results in the study were consistent with the profile of the GLP-1 class, with gastrointestinal side effects proving to be the most common such as nausea, diarrhea, and vomiting.
- Price Action: LLY shares closed at $196.5 on Wednesday.
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