| Study | ALZ2002 | ALZ2004 |
|---|
| Period | Double-blind | Double-blind | Open-label |
|---|
| Treatment group | Placebo | Ata 10 mg | Ata 50 mg | Placebo | Ata 10 mg | Ata 25 mg | Placebo/5 mg | Placebo/25 mg | 5 mg | 25 mg |
|---|
| AST or ALT,n | 39 | 34 | 37 | 35 | 29 | 26 | 15 | 14 | 26 | 22 |
| > ULN to ≤ 2× ULN,n(%) | 0 | 5 (14.7) | 8 (21.6) | 2 (5.7) | 1 (3.4) | 7 (26.9) | 4 (26.7) | 2 (14.3) | 3 (11.5) | 7 (31.8) |
| > 2× ULN to ≤ 3× ULN,n(%) | 0 | 2 (5.9) | 1 (2.7) | 0 | 2 (6.9) | 1 (3.8) | 0 | 2 (14.3) | 0 | 0 |
| > 3× ULN,n(%) | 1 (2.6) | 2 (5.9) | 2 (5.4) | 0 | 2 (6.9) | 1 (3.8) | 1 (6.7) | 3 (21.4) | 0 | 0 |
- ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal
- For double-blind period 1, baseline is defined as the pre-dose baseline value from the preceding parent ALZ2002 study. For open-label period 2, baseline is defined as the last value taken on or before the day of the first dose of study drug in the open-label period
