Table 3.
Exclusion Criteria Applied to Patient Sample, for REGENERATE Clinical Trial
| Exclusion Criteria | Excluded from Study | Not Excluded |
|---|---|---|
| Significant alcohol use | 25 (10.6%) | 212 (89.5%) |
| Ileal resection of bariatric surgery in antecedent 5 years | 1 (0.4%) | 236 (99.6%) |
| HbA1c > 9.5% within 60 days | 10 (4.2%) | 227 (95.8%) |
| Other chronic liver disease | 59 (24.9%) | 178 (75.1%) |
| Histological cirrhosis | 58 (24.6%) | 179 (75.4%) |
| MELD score > 12 | 9 (3.8%) | 228 (96.2%) |
| Known or suspected hepatocellular carcinoma | 10 (4.2%) | 227 (95.8%) |
| Total bilirubin >1.5 | 21 (8.9%) | 216 (91.1%) |
| Conjugated bilirubin ≥ 1.5 ULN | 21 (8.9%) | 216 (91.1%) |
| AST or ALT ≥ 10x ULN | 5 (2.1%) | 232 (97.9%) |
| Creatinine ≥ 1.5 | 7 (3.0%) | 230 (97.0%) |
| Creatine phosphokinase >5x ULN | 0 (0.0%) | 237 (100.0%) |
| Platelet count < 100,000 | 54 (22.8%) | 183 (77.2%) |
| LDL ≥ 190 on statin or PCSK9 inhibitor | 1 (0.4%) | 236 (99.6%) |
| History of biliary diversion | 0 (0.0%) | 237 (100.0%) |
| HIV Infection | 1 (0.4%) | 236 (99.6%) |
| Significant atherosclerotic cardiovascular disease in past year | 4 (1.7%) | 233 (98.3%) |
| Known substance abuse in past 1 year | 6 (2.5%) | 231 (97.5%) |
| Pregnancy | 0 (0.0%) | 237 (100.0%) |
| Receipt of any investigational product not for DM2, weight loss, or NASH in past 6 months | 2 (0.8%) | 235 (99.2%) |
| Previous exposure to OCA | 0 (0.0%) | 237 (100.0%) |
| Acute cholecystitis or acute biliary obstruction | 0 (0.0%) | 237 (100%) |
| BMI >45 with comorbid high BP, HLD, or DM2 | 7 (3.0%) | 230 (97.1%) |
| Meeting any exclusion criteria | 150 (63.3%) | 87 (36.7%) |