Eli Lilly's Tirzepatide Non-Inferior To Titrated Insulin Glargine In Type 2 Diabetes Patients

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.