Study design and treatment
sHTG
Adults aged 18 to 75 years with sHTG (fasting serum triglycerides >500 mg dlPatients in each cohort were randomized 2:1 to receive either i.v. evinacumab 15 mg kgThe primary end point of the study was to determine the intra-patient percent change in mean serum triglycerides from baseline following 12 weeks of evinacumab treatment in cohort 3 patients (the 12 weeks of treatment encompassed a combination of the DBTP and SBTP). Cohort 3 was prespecified as the analysis population for the primary end point analysis, as this group of patients had an intact LPL pathway and would thus be expected to respond optimally to evinacumab treatment. To reduce the variability of baseline triglyceride measurements for patients randomized to evinacumab in the DBTP, baseline was defined as the geometric mean of all available triglyceride results at days –28, –14 and 1. Similarly, for those switching from placebo to evinacumab in the SBTP, baseline was defined as the geometric mean of all available triglyceride results at weeks 6, 8 and 12. The percent change in other lipid/lipoprotein parameters from baseline to weeks 12 and 24 were also evaluated.