The primary completion date for the SURPASS-CVOT trial is set for June 2025. To date, the only officially confirmed presentation related to this trial is scheduled during the ADA Scientific Sessions, where Dr. Ostrominski is expected to discuss findings on June 21, 2025. However, it’s important to note that this presentation is not confirmed to include full results from the trial itself.
In 2024, researchers expressed concern based on preliminary, non-public data suggesting the trial had not yet reached the required number of major adverse cardiovascular events (MACE). Notably, the dulaglutide (Trulicity) treatment arm was trending toward fewer MACE events compared to tirzepatide (Mounjaro), which may have contributed to the delay. As a result, the trial was extended to meet the pre-specified event threshold necessary for statistical power.
Shortly after, a separate study was initiated: Emulation of the Study of Tirzepatide Compared with Dulaglutide on Major Cardiovascular Events in Participants with Type 2 Diabetes, often referred to as the “emulated SURPASS-CVOT.” This study, launched in 2024 and also projected to conclude by June 2025, uses insurance claims data in a retrospective observational framework designed to mimic the original SURPASS-CVOT trial’s methodology.
The purpose of this emulated study appears to be strategic: it may offer supportive data using real-world evidence in the event that the actual SURPASS-CVOT trial yields less favorable outcomes for tirzepatide. However, as a non-randomized, retrospective cohort analysis, the emulated study inherently carries limitations in causal inference and is not a substitute for the rigor of the original randomized controlled trial.
