Lilly’s Trulicity meets primary efficacy objective in REWIND trial

Trulicity significantly reduced major adverse cardiovascular events, or MACE, a composite endpoint of cardiovascular, or CV, death, non-fatal myocardial infarction or non-fatal stroke, meeting the primary efficacy objective in the REWIND trial. Eli Lilly’s once-weekly Trulicity is the first type 2 diabetes medicine to demonstrate superiority in the reduction of MACE events in a clinical trial that included a majority of participants who did not have established CV disease. The study included a majority of patients without established CV disease at baseline, a first for the GLP-1 receptor agonist class. REWIND assessed the risk of MACE in adults with type 2 diabetes with a wide range of CV risk. The study compared the effect of once-weekly Trulicity 1.5 mg to placebo when added to standard of care. REWIND is distinct compared to other CV outcome trials due to the limited number of people with established CV disease who participated in the trial, allowing Trulicity’s CV effect to be measured in a broad population of people with type 2 diabetes. Importantly, REWIND had a median follow-up period of more than 5 years, the longest for a CV outcome trial in the GLP-1 receptor agonist class. In comparison, other CV outcome trials had more people with a higher baseline A1C and a greater percentage of patients who had established CV disease. Of the 9,901 REWIND participants, the mean baseline A1C was relatively lower at 7.3%, and only 31% had established CV disease. The safety profile of Trulicity in REWIND was generally consistent with the GLP-1 receptor agonist class. Lilly plans to submit these data to regulatory authorities next year and to share detailed results at the American Diabetes Association Scientific Sessions in 2019.

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