Table 4: Change in lipids and liver enzymes in the phase II MGL-3196-05, 36-week main study47.
| Placebo, % mean (SE) | Resmetirom, % mean (SE) | Least-squares mean difference, % (95% CI) | p-value | |
|---|---|---|---|---|
| LDL-C, mg/dL | 6.2 (3.1) | -11.2% (2.1) | -17.3% (-24.8, -9.9) | <0.0001 |
| HDL-C, mg/dL | 2.2 (3.4) | 6.0% (2.3) | 3.8% (-4.4, 12.0) | 0.36 |
| Lp(a) (baseline >10 nmol/L), nmol/L | 15.3% (8.9) | -22.7% (6.3) | -37.9% (-59.7, -16.2) | 0.0009 |
| Apolipoprotein B (baseline LDL-C ≥100 mg/dL), mg/dL | 7.4% (3.5) | -20.2% (2.5) | -27.6% (-36, -19.1) | <0.0001 |
| Triglycerides, mg/dL | 20.5% (5.5) | -15.4% (3.8) | -36.0% (-49.2, -22.7) | <0.0001 |
| Apolipoprotein CIII, mg/dL | 24.5% (5.4) | -12.0% (3.7) | -36.5% (-49.6, -23.5) | <0.0001 |
| Alanine aminotransferase, IU/L | ||||
| Week 12 Week 36 | -5.2 (3.9) 11.0 (6.8) | -8.2 (2.7) -15.4 (4.7) | -3.0 (-12.4, 6.4) -26.4 (-42.8, -9.9) | 0.53 0.0019 |
| Aspartate aminotransferase, IU/L | ||||
| Week 12 Week 36 | -1.1 (2.5) 3.6 (2.8) | -5.8 (1.8) -7.4 (1.9) | -4.8 (-10.9, 1.4) -11.1 (-17.8, -4.3) | 0.13 0.0016 |
| Gamma-glutamyl transpeptidase, IU/L | 49.4 (15.2) | -9.1 (10.4) | -58.5 (-95.2, -21.8) | 0.002 |
| Reverse triiodothyronine, ng/dL | -1.37 (0.73) | -4.26 (0.50) | -2.88 (-4.64, -1.12) | <0.0001 |
Resmetirom therapy was associated with a statistically significant reduction in atherogenic lipids and liver enzymes at Week 36. Resmetirom significantly decreased serum reverse triiodothyronine.
CI = confidence interval; HDL-C = high-density lipoprotein-cholesterol; LDL-C = low-density lipoprotein-cholesterol; Lp(a) = Lipoprotein (a); SE = standard error.