Wednesday, September 04, 2019 2:44:39 PM
Secondly, we want to report out results on non-HDL-cholesterol, then followed by VLDL and then HDL, and then finally, LDL and hemoglobin A1c. It's important to note that the TRILOGY protocol requires our physician investigators to determine if patients who presented at screening with high LDL and/or high hemoglobin A1c levels, be put on standard therapies such as statins or short-acting diabetes meds. If so, those patients had to show that their LDL and hemoglobin A1c levels had stabilized prior to being randomized into the TRILOGY study. Therefore, we hope to show any incremental benefited CaPre above and beyond the standard of care. The results with both LDL and hemoglobin A1c will require subgroup analyses, which will be done by combining CaPre results from diabetic patients and separately CaPre results from patients with high LDL from both studies to reach adequate statistical power to detect the difference from the respective placebo groups, if one exist.
Now Acasti expects that the remaining numerous secondary and exploratory endpoints along with various additional subgroup analyses should be completed before the end of March 2020. In addition to our preliminary top line data, we'll seek to present the full data set, which will include results for all of our key secondary and exploratory endpoints of interest such as non-HDL, VLDL, HDL, LDL-cholesterol and hemoglobin A1c and others. And we plan to present these at key scientific meetings in the first half of 2020, potentially including the American College of Cardiology in March, the National Lipid Association in May and the American Diabetes Association in June. We plan to communicate more information in the months ahead on how and when all of the TRILOGY results will be reported once the statistical analysis plan is finalized.
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