Table 2 Design characteristics of 630 drug interventional NAFLD clinical trials
From: Analyzing MASLD interventional clinical trial registration based on the ClinicalTrials.gov database
|  | 2000–2012 (n = 110) | 2013–2024 (n = 520) | total (n = 630) |
|---|---|---|---|
Phase | |||
   Early phase1 | 1 (0.91%) | 8 (1.54%) | 9 (1.43%) |
   Phase 1 | 7 (6.36%) | 129 (24.81%) | 136 (21.59%) |
   Phase1/2 | 6 (5.45%) | 19 (3.65%) | 25 (3.97%) |
   Phase 2 | 47 (42.73%) | 222 (42.69%) | 269 (42.70%) |
   Phase 2/3 | 6 (5.45%) | 3 (0.58%) | 9 (1.43%) |
   Phase 3 | 12 (10.91%) | 46 (8.85%) | 58 (9.21%) |
   Phase 4 | 17 (15.45%) | 61 (11.73%) | 78 (12.38%) |
   NA | 14 (12.73%) | 32 (6.15%) | 46 (7.30%) |
Participant | |||
   Children | 5 (4.55%) | 9 (1.73%) | 14 (2.22%) |
   Adults | 97 (88.18%) | 497 (95.58%) | 594 (94.29%) |
   Both | 8 (7.27%) | 14 (2.69%) | 22 (3.49%) |
Study Status | |||
   Active Not Recruiting | 1 (0.91%) | 25 (4.81%) | 26 (4.13%) |
   Enrolling by Invitation | 0 (0.00%) | 3 (0.58%) | 3 (0.48%) |
   Not Yet Recruiting | 0 (0.00%) | 26 (5.00%) | 26 (4.13%) |
   Recruiting | 0 (0.00%) | 103 (19.81%) | 103 (16.35%) |
   Completed | 80 (72.73%) | 277 (53.27%) | 357 (56.67%) |
   Suspended | 1 (0.91%) | 1 (0.19%) | 2 (0.32%) |
   Terminated | 18 (16.36%) | 47 (9.04%) | 65 (10.32%) |
   Unknown | 10 (9.09%) | 38 (7.31%) | 48 (7.62%) |
Study Results | |||
   Yes | 43 (39.09%) | 115 (22.12%) | 158 (25.08%) |
   No | 67 (60.91%) | 405 (77.88%) | 472 (74.92%) |
Sex | |||
   Female | 2 (1.82%) | 11 (2.12%) | 13 (2.06%) |
   Male | 3 (2.73%) | 22 (4.23%) | 25 (3.97%) |
   All | 105 (95.45%) | 487 (93.65%) | 592 (93.97%) |
Masking | |||
   Single | 12 (10.91%) | 27 (5.19%) | 39 (6.19%) |
   Double | 20 (18.18%) | 91 (17.50%) | 111 (17.62%) |
   Triple | 23 (20.91%) | 72 (13.85%) | 95 (15.08%) |
   Quadruple | 21 (19.09%) | 169 (32.50%) | 190 (30.16%) |
   None | 32 (29.09%) | 161 (30.96%) | 193 (30.63%) |
   NA | 2 (1.82%) | 0 (0.00%) | 2 (0.32%) |
Assignment | |||
   Parallel | 77 (70.00%) | 409 (78.65%) | 486 (77.14%) |
   Crossover | 1 (0.91%) | 13 (2.50%) | 14 (2.22%) |
   Single Group | 28 (25.45%) | 54 (10.38%) | 82 (13.02%) |
   Sequential | 0 (0.00%) | 35 (6.73%) | 35 (5.56%) |
   Factorial | 1 (0.91%) | 8 (1.54%) | 9 (1.43%) |
   NA | 3 (2.73%) | 1 (0.19%) | 4 (0.63%) |
Allocation | |||
   Randomized | 83 (75.45%) | 434 (83.46%) | 517 (82.06%) |
   Non-Randomized | 5 (4.55%) | 38 (7.31%) | 43 (6.83%) |
   NA | 22 (20.00%) | 48 (9.23%) | 70 (11.11%) |
Sample Size | |||
   1–50 | 56 (50.91%) | 178 (34.23%) | 234 (37.14%) |
   51–100 | 28 (25.45%) | 158 (30.38%) | 186 (29.52%) |
   101–200 | 19 (17.27%) | 114 (21.92%) | 133 (21.11%) |
   201–500 | 5 (4.55%) | 48 (9.23%) | 53 (8.41%) |
   501–1000 | 0 (0.00%) | 11 (2.12%) | 11 (1.75%) |
   >1000 | 1 (0.91%) | 11 (2.12%) | 12 (1.90%) |
   NA | 1 (0.91%) | 0 (0.00%) | 1 (0.16%) |