Table 5: Results of the liver biopsy from the 36-week MGL-3196-05 study.

Change in NAS at liver biopsy	n	Placebo	n	Resmetirom	Least square mean difference (95% CI)	p-value
Overall, change in NAS mean (SE)	34	-1.0 (0.21)	73	-1.4 (0.14)	-0.4 (0.9–0.1)	0.082
High exposure group	-		43	-1.6 (0.18)	-0.6 (-1.2, 0.1)	0.029
Low exposure group			30	-1.2 (0.22)	-0.2 (-0.8, 0.4)	0.51
High SHBG group			44	-1.7 (0.18)	-0.7 (-1.2, -0.1)	0.016
Low SHBG group			29	-1.1 (0.22)	-0.1 (-0.7, 0.5)	0.77
MRI-PDFF responders by Week 12 (>30% reduction)			46	-1.9 (0.16)	-0.9 (-1.4 to 0.4)	0.0006

Subgroup analyses identified factors associated with greater histologic response. No significant difference in overall NAS was seen with resmetirom vs placebo. In those with high drug exposure compared with low exposure ( assessed by 24 h area under the curve), high SHBG levels (defined as an 88% increase from baseline), compared with low SHBG, and those who had a ≥30% fat reduction (assessed by MRI-PDFF) had a statistically significant decrease in NAS.

MRI-PDFF = magnetic resonance imaging proton density fat fraction; NAS = non-alcoholic fatty liver disease score; SHBG = sex hormone binding globulin.