Table 1.
Demographics, baseline and post-treatment characteristics [mean (SD)] in the intent-to-treat population
| Placebo (N = 47) | AZD4017 (N = 46) | P value | ||||
|---|---|---|---|---|---|---|
| Study site, [MRW]n (%) | 0.903 | |||||
| Mayo Clinic | 27 (57.4%) | 27 (58.7%) | ||||
| University of Virginia | 20 (42.6%) | 19 (41.3%) | ||||
| Subgroup | 0.947 | |||||
| NAFLD | 10 (21.3%) | 8 (17.4%) | ||||
| NAFLD T2DM | 4 (8.5%) | 4 (8.7%) | ||||
| NASH | 15 (31.9%) | 17 (37.0%) | ||||
| NASH T2DM | 18 (38.3%) | 17 (37.0%) | ||||
| Gender (F:M) | 29:18 | 28:18 | 0.934 | |||
| Age (years) | 53.3 (11.4) | 53.7 (11.7) | 0.885 | |||
| BMI (kg/m2) | 36.7 (8.1) | 36.4 (8.1) | 0.841 | |||
| Pre | Post | Pre | Post | Pre | Post | |
| Weight (Kg) | 104.0 (25.5) | 104.3 (26.6) | 100.5 (21.3) | 98.1 (19.6) | 0.477 | 0.343 |
| Total Body Fat (%) | 43.1 (6.1) | 42.9 (6.3) | 42.0 (8.4) | 40.5 (7.7) | 0.504 | 0.203 |
| Abdominal Fat (%) | 47.2 (6.4) | 48.2 (6.6) | 46.1 (8.3) | 45.1 (7.4) | 0.539 | 0.093 |
| Fasting Plasma Glucose (mg/dL) | 128.7 (48.1) | 135.2 (55.3) | 123.5 (46.7) | 129.6 (61.3) | 0.601 | 0.662 |
| HbA1c (%) {mmol/mol} | 6.5(1.4) {48} | 6.6 (1.3) {49} | 6.4 (1.6) {46} | 6.5 (1.4) {48} | 0.831 | 0.715 |
| AST (U/L) | 53.5 (32.8) | 48.8 (45.9) | 43.7 (33.8) | 38.0 (21.4) | 0.165 | 0.176 |
| ALT (U/L) | 63.9 (40.8) | 60.6 (60.3) | 54.4 (43.7) | 41.2 (26.1) | 0.283 | 0.059 |
| Alk phos (IU/L) | 77.6 (25.6) | 74.2 (22.8) | 78.5 (23.1) | 64.9 (20.4) | 0.859 | 0.048 |
| TSH (mU/L) | 2.3 (2.0) | 2.1 (1.3) | 2.7 (4.6) | 2.4 (1.8) | 0.565 | 0.429 |
| Total Bilirubin (mg/dL) | 0.8 (1.0) | 0.5 (0.3) | 0.7 (0.3) | 0.6 (0.3) | 0.73 | 0.240 |
| Direct Bilirubin (mg/dL) | 0.2 (0.1) | 0.2 (0.2) | 0.2 (0.1) | 0.2 (0.1) | 0.469 | 0.813 |
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; BMI, body mass index; F, female; M, male; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; T2DM, type 2 diabetes; TSH, thyroid-stimulating hormone