Table 1.
Baseline characteristics of the patients in the aleglitazar group compared with the placebo group.
Fig 1.
Change in NITs of liver steatosis and fibrosis from baseline.
Value at baseline for A: Median LFS of 0.60 for placebo and 0.63 for aleglitazar, B: Mean LAP of 69.5 for placebo and 67.8 for aleglitazar, C: Mean FIB-4 of 1.40 for placebo and 1.44 for aleglitazar, D: Mean NFS of -0.50 for placebo and -0.41 for aleglitazar. Error bars indicate 95% CIs. Change from baseline is significantly different in the aleglitazar and the placebo group at all timepoints ≥3 mohs for all proxies (all P<0.001).
Fig 2.
Change in AST/ALT ratio and BMI from baseline.
Value at baseline for A: Mean AST/ALT of 1.21 for placebo and 1.22 for aleglitazar, B: Mean BMI of 29.5 kg/m2 for placebo and 29.3 kg/m2 for aleglitazar. Error bars indicate 95% CIs. Change from baseline is significantly different in the aleglitazar and the placebo group at all timepoints ≥1 month for both AST/ALT ratio and BMI (all P<0.001).
Table 2.
Changes in absolute values of non-invasive tests over time.
Fig 3.
Change in FIB-4 and NFS category from baseline until 24 months follow-up.
Proportion of randomized patients that either improved (changed to a lower category), worsened (changed to a higher category) or did not change in category. Proportion of change is significantly different between treatment and placebo for FIB-4 (A) and NFS (B). FIB-4: Both improvement and worsening P<0.001, NFS: Improvement P<0.004, worsening P = 0.024.
Fig 4.
Change in LFS and LAP compared to cut-off values at baseline until 24 months follow-up.
Proportion of randomized patients that either improved (lnLAP below cut-off <4 for males and <4.4 for females, LFS below cut-of <-0.640), worsened (lnLAP above cut-off >4 for males and >4.4 for females, LFS above cut-off >-0.064), or did not change in respect to respective cut-off value. Proportion of change is significantly different between treatment and placebo for LAP (A), both improvement and worsening P<0.001. For LFS (B) only worsening is significantly less in the treatment group, improvement P = 0.974, worsening P = 0.031.