Statistical analysis
weight loss, TG
The planned sample size of 150 patients was randomized 2:1 to receive either PEG-Loxe or metformin. This sample size was expected to provide a power of 80% to detect a difference of ≥2 kg weight loss between the PEG-Loxe and metformin groups, with a standard deviation (SD) of 3.66 (The normal distribution of variables was evaluated using the Kolmogorov-Smirnov test and by assessment of residual distribution. Baseline variables were analyzed using independent t test, Mann-Whitney U test, and χ² test.The efficacy analyses were evaluated using the full analysis set, defined as patients exposed to ≥1 treatment dose and had a baseline assessment. Safety data were assessed using the safety analysis set, defined as patients exposed to ≥1 treatment dose. The primary endpoint (change in body weight) was analyzed using a mixed model for repeated measurements (MMRM), which included group, time, and the corresponding interactions as fixed effects, and baseline weight and sex as covariates. MMRM was used to analyze BMI, WC, VFA, HbA1c, FPG, C-peptide, HOMA-B, HOMA-S, TC, TG, LDL-C, HDL-C, SBP, DBP, ALT, AST, and pulse rate. Categorical variables were evaluated using the χ² test or Fisher exact test. Missing data were imputed using a multiple linear imputation analysis according to the rules of Rubin (Results are shown as adjusted mean and 95% CI, if not indicated otherwise. A 