Shares of Eli Lilly and Company (NYSE:LLY) dropped Thursday morning after the company announced that its diabetes treatment Mounjaro did not demonstrate superiority over Trulicity, its older GLP-1 medication, in a major cardiovascular trial.
Following the release of topline findings from the SURPASS-CVOT study, which compared both treatments in adults with type 2 diabetes and established cardiovascular disease, Lilly’s stock initially fell as much as 4.5% before trimming losses to around 2.25%.
Mounjaro succeeded in meeting the trial’s primary goal of non-inferiority, showing an 8% reduction in major adverse cardiovascular events (MACE-3) compared to Trulicity. However, the drug did not meet the statistical threshold required to claim superiority. The trial reported a hazard ratio of 0.92 with a 95.3% confidence interval of 0.83 to 1.01, narrowly missing the cutoff for significance.
On the positive side, the study did report favorable secondary outcomes for Mounjaro, including a 16% reduction in all-cause mortality relative to Trulicity, as well as improvements in A1C, weight loss, and kidney function. Still, these results were not adjusted for multiplicity and thus cannot be considered definitive.
Michael Shah, an analyst at Bloomberg Intelligence, characterized the results as both encouraging and disappointing.
“Eli Lilly’s Mounjaro met the primary endpoint in the SURPASS-CVOT trial, demonstrating a non-inferior rate of major adverse cardiovascular events vs. Trulicity. Yet this is undermined by the fact that the trial also tested for superiority, but that was not achieved (or at least not disclosed in the initial release). The commercial implications could be limited, as prescribers generally view Mounjaro as a more effective GLP-1 than Trulicity.”
Eli Lilly stated that it will present full trial data at the European Association for the Study of Diabetes Annual Meeting in September, with plans to submit the findings to regulatory agencies globally by the end of the year.
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