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In the GOLDEN‐505 trial of elafibranor for NASH, higher baseline ALT was associated with more active histological disease and declines during the trial were associated with histological improvement, with NASH resolution associated with the strongest time‐dependent ALT reductions.48 In the FLINT trial of obeticholic acid for NASH, a week 24 ALT reduction ≥17 U/L independently predicted week 72 histological response.49 Furthermore, in the PIVENS trial, normalisation of elevated ALT at week 24 (a ≥30% reduction from baseline resulting in a level ≤40 U/L) without subsequent relapse was strongly associated with histological improvement of NASH activity at week 96 among subjects receiving either vitamin E or placebo.27 Finally, normalisation of high baseline ALT has independently predicted fibrosis improvement in patients with NASH given 1 year of lifestyle intervention.50 Elevated hsCRP is predictive of both type 2 diabetes51 and cardiovascular risk,52 and is a risk factor for steatosis.26, 53, 54, 55, 56, 57, 58 However, its association with NASH is less clearly defined: some studies show no association between hsCRP and the severity of NAFLD,55, 56 while others found that hsCRP can discriminate between steatosis and NASH, particularly more severe NASH,26, 57, 58 and is associated with underlying fibrosis.26, 57 Thus, ALT and hsCRP may reflect different aspects of the pathogenic process, and their mutual reduction may represent separate treatment effects

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(2023a)