TABLE 2.
Change from baseline to end of study for key efficacy assessments
| Parameter | Baseline | EOS | Median change from baseline to EOS a | ULN or LLN |
|---|---|---|---|---|
| ALT | n = 8 | n = 7 | n = 7 | |
| Median (range), U/L | 81.5 (36‐109) | 54.0 (24‐80) | −43.0 (−63 to 18) | ULN = 67 U/L |
| AST | n = 8 | n = 7 | n = 7 | |
| Median (range), U/L | 50.0 (29‐64) | 34.0 (23‐47) | −16.0 (−30 to 9) | ULN = 50 U/L |
| GGT | n = 8 | n = 7 | n = 7 | |
| Median (range), U/L | 29.5 (14‐148) | 28.0 (7‐134) | −4.0 (−14 to 10) | ULN = 73 U/L |
| TC | n = 8 | n = 7 | n = 7 | |
| Median (range), mg/dL | 170.7 (103‐311) | 132.3 (99‐250) | −20.1 (−135 to 68) | ULN = 232 mg/dL |
| TG | n = 8 | n = 7 | n = 7 | |
| Median (range), mg/dL | 104.1 (54‐336) | 112.5 (52‐287) | −1.8 (−161 to 166) | ULN = 199 mg/dL |
| LDL‐C | n = 8 | n = 7 | n = 7 | |
| Median (range), mg/dL | 113.1 (66‐297) | 78.1 (54‐187) | −20.1 (−123 to 9) | ULN = 162 mg/dL |
| HDL‐C | n = 8 | n = 7 | n = 7 | |
| Median (range), mg/dL | 36.9 (19‐51) | 42.2 (21‐70) | 8.1 (−5 to 19) | LLN = 35 mg/dL |
| Liver volume | n = 8 | n = 5 | n = 5 | |
| Median (range), MN b | 1.00 (0.87‐1.24) | 0.82 (0.71‐1.13) c | −0.17 (−0.26 to −0.11) | |
| Liver fat content | n = 5 | n = 4 | n = 3 | |
| Median (range), % | 10.41 (4.00‐12.29) | 3.47 (1.30‐4.12) c | −3.91 (−7.48 to −0.63) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; EOS, end of study; GGT, γ‐glutamyltransferase; HDL‐C, high‐density lipoprotein cholesterol; LDL‐C, low‐density lipoprotein cholesterol; LLN, lower limit of normal; MN, multiples of normal; TC, total cholesterol; TG, triglycerides; ULN, upper limit of normal.
a
Median change from baseline values is reported for only those patients who had both baseline and end‐of‐study data.
b
Normal = 2.5% of body weight.
c
Week 208 (last time point with n >2).