Statistical analysis
TG
The study was designed to have at least 86% power to detect a 45% difference in TG between each of the pegozafermin arms and placebo groups, assuming 50% reduction in pegozafermin dose groups and 5% reduction in the placebo group. Both pooled pegozafermin from all dose groups and individual pegozafermin dose groups were compared with placebo. All analyses were performed at a two-sided Efficacy analyses were conducted with the full analysis set, which included patients with at least one postbaseline TG level. Normality test was performed and if normality was severely violated, then nonparametric tests were performed. A prespecified QQ plot suggested that the distribution of TG data was highly skewed and deviated from the normality assumption required for the mixed models for repeated measures (MMRM) method. Therefore, the primary efficacy analysis was performed using a nonparametric van Elteren test, stratified by baseline TG level and background lipid therapy, to test the treatment difference using pooled data. The location shift estimate and Hodges–Lehmann two-tailed 95% CI are presented. A comparison between the individual pegozafermin dose group and placebo used the unstratified Wilcoxon rank-sum test due to low sample size. If the number of participants within any subgroup was too low for meaningful comparison (Secondary efficacy endpoints were analyzed by MMRM. If the mixed model assumption was severely violated, nonparametric methods were used for the analysis. The proportion of participants with TG < 500 mg dl