Table 3: Changes in hepatic fat content in the phase II MGL-3196-05, 36 week main study1.
| Resmetirom 80 mg, % (SE) | Placebo, % (SE) | Least-squares difference from baseline, % (95% Cl) | Odds ratio for NASH resolution (95% Cl) | p-value | |
|---|---|---|---|---|---|
| Relative change in MRI-PDFF from baseline to Week 12, | -32.9 (3.0) | -10.4 (4.3) | -22.5 (-32.9,-12.2) | N/A | <0.0001 |
| Relative change in MRI-PDFF from baseline to Week 36 | -37.3 (3.7) | -8.9 (5.4) | -28.4 (-41.3,-15.4) | N/A | <0.0001 |
| Absolute change in MRI-PDFF from baseline to Week 12 | -7.0 (0.6) | -2.7 (0.8) | -4.3 (-6.3, -2.4) | N/A | <0.0001 |
| Absolute change in MRI-PDFF from baseline to Week 36 | -8.2 (0.7) | -2.8 (1.1) | -5.3 (-7.8, -2.8) | N/A | <0.001 |
| Liver biopsy at Week 36, change in NAS | -1.4 (0.14)* | -1.0 (0.21)* | -0.4 (-0.9, 0.1) | N/A | 0.082 |
| Patients with >30% fat reduction at Week 12 | 60.30+ | 18.40+ | N/A | 6.8 (2.6-17.6) | <0.0001 |
| Patients with >30% fat reduction at Week 36 | 67.60+ | 29.40+ | N/A | 4.9 (2.0-11.9) | 0.0006 |
At both week 12 of treatment (primary endpoint) and week 36, resmetirom-treated patients (n=78) demonstrated both a relative and an absolute reduction of hepatic fat as assessed by MRI-PDFF when compared with placebo (n=38). Those that had a >30% reduction in hepatic fat at 12 and 36 weeks had an odds ratio of 6.8 and 4.9, respectively for achieving NASH resolution.
*Values are mean (SE).
fValues are %.
Cl = confidence interval; MRI-PDFF = magnetic resonance imaging proton density fat fraction; N/A = not applicable; NAS = non-alcoholic fatty liver disease score; NASH = non-alcoholic steatohepatitis; SE = standard error.