Table 1 Basic characteristics of 1209 interventional NAFLD clinical trials
From: Analyzing MASLD interventional clinical trial registration based on the ClinicalTrials.gov database
|  | 2000–2012 (n = 199) | 2013–2024 (n = 1010) | total (n = 1209) |
|---|---|---|---|
Study Status | |||
   Active Not Recruiting | 3 (1.51%) | 45 (4.46%) | 48 (3.97%) |
   Enrolling by Invitation | 0 (0.00%) | 11 (1.09%) | 11 (0.91%) |
   Not Yet Recruiting | 0 (0.00%) | 47 (4.65%) | 47 (3.89%) |
   Recruiting | 2 (1.01%) | 207 (20.50%) | 209 (17.29%) |
   Completed | 143 (71.86%) | 479 (47.43%) | 622 (51.45%) |
   Suspended | 1 (0.50%) | 2 (0.20%) | 3 (0.25%) |
   Terminated | 23 (11.56%) | 61 (6.04%) | 84 (6.95%) |
   Unknown | 22 (11.06%) | 129 (12.77%) | 151 (12.49%) |
   Withdrawn | 5 (2.51%) | 29 (2.87%) | 34 (2.81%) |
Study Results | |||
   Yes | 54 (27.14%) | 144 (14.26%) | 198 (16.38%) |
   No | 145 (72.86%) | 866 (85.74%) | 1011 (83.62%) |
Sex | |||
   Female | 3 (1.51%) | 20 (1.98%) | 23 (1.90%) |
   Male | 10 (5.03%) | 37 (3.66%) | 47 (3.89%) |
   All | 186 (93.47%) | 953 (94.36%) | 1139 (94.21%) |
Participant | |||
   Children | 9 (4.52%) | 30 (2.97%) | 39 (3.23%) |
   Adults | 172 (86.43%) | 936 (92.67%) | 1108 (91.65%) |
   Both | 18 (9.05%) | 44 (4.36%) | 62 (5.13%) |
Phase | |||
   Early phase1 | 1 (0.50%) | 12 (1.19%) | 13(1.08%) |
   Phase 1 | 8 (4.02%) | 144 (14.26%) | 152(12.57%) |
   Phase1/2 | 8 (4.02%) | 26 (2.57%) | 34(2.81%) |
   Phase 2 | 59 (29.65%) | 242 (23.96%) | 301(24.90%) |
   Phase 2/3 | 9 (4.52%) | 10 (0.99%) | 19(1.57%) |
   Phase 3 | 18 (9.05%) | 54 (5.35%) | 72 (5.96%) |
   Phase 4 | 19 (9.55%) | 65 (6.44%) | 84 (6.95%) |
   NA | 77 (38.69%) | 457 (45.25%) | 534 (44.17%) |
Masking | |||
   Single | 22 (11.06%) | 92 (9.11%) | 114 (9.43%) |
   Double | 26 (13.07%) | 149 (14.75%) | 175 (14.47%) |
   Triple | 31 (15.58%) | 102 (10.10%) | 133 (11.00%) |
   Quadruple | 33 (16.58%) | 233 (23.07%) | 266 (22.00%) |
   None | 83 (41.71%) | 434 (42.97%) | 517 (42.76%) |
   NA | 4 (2.01%) | 0 (0.00%) | 4 (0.33%) |
Assignment | |||
   Parallel | 131 (65.83%) | 742 (73.47%) | 873 (72.21%) |
   Crossover | 7 (3.52%) | 35 (3.47%) | 42 (3.47%) |
   Single Group | 54 (27.14%) | 178 (17.62%) | 232 (19.19%) |
   Sequential | 0 (0.00%) | 45 (4.46%) | 45 (3.72%) |
   Factorial | 2 (1.01%) | 9 (0.89%) | 11 (0.91%) |
   NA | 5 (2.51%) | 1 (0.10%) | 6 (0.50%) |
Allocation | |||
   Randomized | 140 (70.35%) | 765 (75.74%) | 905 (74.86%) |
   Non-randomized | 18 (9.05%) | 79 (7.82%) | 97 (8.02%) |
   NA | 41 (20.60%) | 166 (16.44%) | 207 (17.12%) |
Sample Size | |||
   1–50 | 105 (52.76%) | 415 (41.09%) | 520 (43.01%) |
   51–100 | 50 (25.13%) | 283 (28.02%) | 333 (27.54%) |
   101–200 | 29 (14.57%) | 185 (18.32%) | 214 (17.70%) |
   201–500 | 8 (4.02%) | 83 (8.22%) | 91 (7.53%) |
   501–1000 | 1 (0.50%) | 21 (2.08%) | 22 (1.82%) |
   >1000 | 3 (1.51%) | 23 (2.28%) | 26 (2.15%) |
   NA | 3 (1.51%) | 0 (0.00%) | 3(0.25%) |
Purpose | |||
   Treatment | 144 (72.36%) | 747 (73.96%) | 891 (73.70%) |
   Diagnostic | 12 (6.03%) | 56 (5.54%) | 68(5.62%) |
   Basic science | 19 (9.55%) | 83 (8.22%) | 102(8.44%) |
   Supportive care | 3 (1.51%) | 21 (2.08%) | 24(1.99%) |
   Health Services Research | 1 (0.50%) | 5 (0.50%) | 6 (0.50%) |
   Prevention | 10 (5.03%) | 42 (4.16%) | 52 (4.30%) |
   Screening | 1 (0.50%) | 17 (1.68%) | 18 (1.49%) |
   Other | 3 (1.51%) | 39 (3.86%) | 42 (3.47%) |
   NA | 6 (3.02%) | 0 (0.00%) | 6 (0.50%) |
Interventions | |||
   drugs | 113 (56.78%) | 541 (53.56%) | 654 (54.09%) |
   Behavioral | 18 (9.05%) | 88 (8.71%) | 106 (8.77%) |
   Biological | 3 (1.51%) | 14 (1.39%) | 17 (1.41%) |
   Device | 10 (5.03%) | 46 (4.55%) | 56 (4.63%) |
   Dietary Supplement | 29 (14.57%) | 137 (13.56%) | 166 (13.73%) |
   Diagnostic Test | 0 (0.00%) | 42 (4.16%) | 42 (3.47%) |
   Combination Product | 0 (0.00%) | 6 (0.59%) | 6 (0.50%) |
   Procedure | 7 (3.52%) | 27 (2.67%) | 34 (2.81%) |
   Genetic | 0 (0.00%) | 1 (0.10%) | 1 (0.08%) |
   others | 19 (9.55%) | 108 (10.69%) | 127 (10.50%) |