Table 3.
Mean Change from Open-Label Baseline to Week 12 in Weight and Laboratory Parameters (Safety Population)
| Modal 40 mg Group (N=153) | Modal 80 mg Group (N=136) | |||
|---|---|---|---|---|
| n | Mean (SD) Change | n | Mean (SD) Change | |
| Body weight (kg) | 126 | 0.37 (2.31) | 116 | −0.11 (2.70) |
| Fasting total cholesterol (mg/dL) | 117 | 4.6 (36.6) | 109 | 1.8 (30.0) |
| Fasting LDL cholesterol (mg/dL) | 117 | 2.2 (29.0) | 109 | −2.1 (24.3) |
| Fasting HDL cholesterol (mg/dL) | 117 | 1.8 (13.3) | 109 | 4.0 (11.0) |
| Fasting triglycerides (mg/dL) | 117 | 1.6 (70.9) | 109 | −0.8 (54.4) |
| Fasting blood glucose (mg/dL) | 117 | 2.4 (16.8) | 106 | −0.9 (12.9) |
| Blood prolactin, overall (μg/L) | 124 | 0.22 (12.00) | 112 | 3.01 (35.26) |
| Males | 64 | −0.27 (7.18) | 56 | −0.54 (11.22) |
| Females | 60 | 0.74 (15.64) | 56 | 6.55 (48.55) |
Notes: Modal 40 mg group: Subjects who received 40 mg for most days during the extension phase. Modal 80 mg group: Subjects who received 80 mg for most days during the extension phase.
Abbreviation: SD, standard deviation.