Table 3 |.
Changes from baseline to week 52 in liver- and disease-related parameters
| Placebo | Aramchol 400 mg | Aramchol 600 mg | |
|---|---|---|---|
| Liver enzymes | |||
| Number of patients | 47 | 100 | 98 |
| ALT (U l−1) change from baseline to week 52 | 11.77 ± 5.24 | −12.00 ± 3.62 | −17.29 ± 3.72 |
| Difference when compared to placebo | −23.76 ± 6.32 | −29.06 ± 6.37 | |
| P | P = 0.0002 | P < 0.0001 | |
| AST (U l−1) change from baseline to week 52 | 6.68 ± 3.50 | −7.21 ± 2.42 | −10.83 ± 2.49 |
| Difference when compared to placebo | −13.88 ± 4.21 | −17.50 ± 4.24 | |
| P | P = 0.0011 | P < 0.0001 | |
| Alkaline phosphatase (U l−1) change from baseline to week 52 | 11.64 ± 4.55 | −3.41 ± 3.15 | −3.76 ± 3.24 |
| Difference when compared to placebo | −15.06 ± 5.52 | −15.40 ± 5.57 | |
| P | P = 0.0068 | P = 0.0061 | |
| γ-glutamyl transpeptidase (U l−1) change from baseline to week 52 | +66.03 ± 22.74 | −1.23 ± 15.71 | −15.18 ± 16.18 |
| Difference when compared to placebo | −67.25 ± 27.62 | −81.21 ± 27.89 | |
| P | P = 0.016 | P = 0.0040 | |
| Total bilirubin (µmol l−1) change from baseline to week 52 | +0.50 ± 0.45 | −0.17 ± 0.32 | −0.31 ± 0.32 |
| Difference when compared to placebo | −0.67 ± 0.55 | −0.81 ± 0.55 | |
| P | P = 0.22 | P = 0.14 | |
| Lipids | |||
| Number of patients | 47 | 100 | 98 |
| Total cholesterol (mmol l−1) change from baseline to week 52 | +0.08 ± 0.11 | +0.11 ± 0.07 | +0.11 ± 0.08 |
| Difference when compared to placebo | 0.02 ± 0.13 | 0.03 ± 0.13 | |
| P | P = 0.85 | P = 0.84 | |
| LDL cholesterol (mmol l−1) change from baseline to week 52 | 0.24 ± 0.10 | 0.26 ± 0.07 | 0.18 ± 0.07 |
| Difference when compared to placebo | 0.02 ± 0.12 | −0.06 ± 0.12 | |
| P | P = 0.85 | P = 0.62 | |
| HDL cholesterol (mmol l−1) change from baseline to week 52 | −0.02 ± 0.03 | −0.04 ± 0.02 | −0.02 ± 0.02 |
| Difference when compared to placebo | −0.02 ± 0.03 | 0.004 ± 0.030 | |
| P | P = 0.49 | P = 0.89 | |
| Triglycerides (mmol l−1) change from baseline to week 52 | +0.08 ± 0.13 | +0.04 ± 0.09 | 0.16 ± 0.09 |
| Difference when compared to placebo | −0.04 ± 0.16 | +0.07 ± 0.16 | |
| P | P = 0.78 | P = 0.64 | |
| Metabolic factors | |||
| Number of patients | n = 47 | n = 99 | n = 96 |
| Glucose, mmol l−1 change from baseline to week 52 | +0.54 ± 0.26 | +0.10 ± 0.18 | +0.01 ± 0.18 |
| Difference when compared to placebo | −0.44 ± 0.31 | −0.53 ± 0.31 | |
| P | P = 0.16 | P = 0.094 | |
| Number of patients | n = 47 | n = 98 | n = 96 |
| HbA1c (%) change from baseline to week 52 | +0.32 ± 0.11 | −0.04 ± 0.08 | −0.13 ± 0.08 |
| Difference when compared to placebo | −0.36 ± 0.13 | −0.45 ± 0.13 | |
| P | P = 0.0061 | P = 0.0008 | |
| Number of patients | n = 47 | n = 99 | n = 98 |
| Weight (kg) change from baseline to week 52 | −0.11 ± 0.59 | −1.26 ± 0.41 | −0.52 ± 0.42 |
| Difference when compared to placebo | −1.15 ± 0.71 | −0.41 ± 0.71 | |
| P | P = 0.11 | P = 0.56 | |
| Number of patients | n = 46 | n = 98 | n = 98 |
| Waist circumference (cm) change from baseline to week 52 | −1.81 ± 1.30 | −2.23 ± 0.89 | −0.63 ± 0.90 |
| Difference when compared to placebo | −0.41 ± 1.55 | 1.19 ± 1.56 | |
| P | P = 0.79 | P = 0.45 | |
| Biomarkers | |||
| Number of patients | n = 46 | n = 100 | n = 95 |
| FIB4 change from baseline to week 52 | +0.17 ± 0.08 | −0.05 ± 0.06 | −0.10 ± 0.06 |
| Difference when compared to placebo | −0.21 ± 0.10 | −0.27 ± 0.10 | |
| P | P = 0.033 | P = 0.008 | |
| Number of patients | n = 42 | n = 91 | n = 89 |
| NFS change from baseline to week 52 | +0.23 ± 0.11 | −0.12 ± 0.08 | −0.04 ± 0.08 |
| Difference when compared to placebo | −0.35 ± 0.13 | −0.27 ± 0.13 | |
| P | P = 0.0080 | P = 0.038 | |
| Number of patients | n = 44 | n = 95 | n = 95 |
| FLI change from baseline to week 52 | 0.59 ± 1.51 | −2.01 ± 1.04 | −1.07 ± 1.06 |
| Difference when compared to placebo | −2.60 ± 1.80 | −1.66 ± 1.80 | |
| P | P = 0.15 | P = 0.36 | |
Results of baseline-adjusted MMRM LSM ± s.e.m. of absolute changes from baseline by treatment group. When there were no repeated measures, analysis of baseline-adjusted covariance was used. Two-sided nominal P values beyond the primary end point was used when testing between active groups and placebo contrasts.