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©The Author(s) 2023.
World J Gastroenterol. Oct 7, 2023; 29(37): 5327-5338
Published online Oct 7, 2023. doi: 10.3748/wjg.v29.i37.5327
Published online Oct 7, 2023. doi: 10.3748/wjg.v29.i37.5327
Table 1 Baseline characteristics of included studies
Ref. | Location sponsor | Study design | Sample size (n) | Demographics (%) | Intervention/comparator(s) | Outcomes assessed |
Newsome et al[20], 2021 | 16 countrie, 143 sites; Novo Nordisk | MC, DB, four-arm parallel-group RCT; duration: 72 wk; randomization: 3:3:3:1:1:1 | 320 | Age (SD): 55.0 (10.6); male/female: 125(39)/195(61); T2DM: 199 (62) | Semaglutide: 0.1 mg SQ OD (n = 80); 0.2 mg SQ OD (n = 78); 0.4 mg SQ OD (n = 82); and placebo (n = 80) | Primary: Resolution of NASH; secondary: Liver fibrosis stage, total and component of NAS, ALT, AST, liver stiffness, liver steatosis, cardiometabolic parameters, adverse events |
Flint et al[21], 2021 | Germany, 2 sites; Novo Nordisk | Two-centre, DB, two-arm parallel-group RCT; duration: 72 wk; randomization: 1:1 | 67 | Age (SD): 60.0 (9.3); male/female: 47(70)/20(30); T2DM: 49 (73) | Semaglutide: 0.4 mg SQ OD (n = 34); placebo (n = 33) | Primary: Liver stiffness MRE at week 48; secondary: Liver stiffness at week 24 and 72, liver steatosis, ALT, AST, cardiometabolic parameters, adverse events |
Loomba et al[17], 2023 | 5 countries, 38 sites; Novo Nordisk | MC, DB, two-arm-parallel group RCT; duration: 48 wk; randomization: 2:1 | 71 | Age (SD): 59.5 (8.0); male/female: 22(31)/49(61); T2DM: 53 (75) | Semaglutide: 2.4 mg SQ qw (n = 47); Placebo (n = 24) | Primary: Liver fibrosis stage; secondary: Liver stiffness, liver steatosis, NASH resolution, total and component of NAS, ALT, AST, cardiometabolic parameters, adverse events |
Table 2 Grading of recommendations assessment, development, and evaluation summary of findings table
Outcomes | Anticipated absolute effects1 (95%CI) | Relative effect (95%CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | |
Risk with placebo | Risk with semaglutide | ||||
Resolution of NASH with no worsening of liver fibrosis assessed with: Liver biopsy | 183 per 1000 | 416 per 1000 (276 to 571) | OR 3.18 (1.70 to 5.95) | 301 (2 RCTs) | +++O: Moderate2 |
Improvement in liver fibrosis stage without worsening of NASH assessed with: Liver biopsy | 317 per 1000 | 248 per 1000 (65 to 613) | OR 0.71 (0.15 to 3.41) | 301 (2 RCTs) | ++OO: Low2,3,4 |
Liver stiffness assessed with: MRI-PDFF or Fibroscan | - | SMD 0.48 lower (0.86 lower to 0.11 lower) | - | 350 (3 RCTs) | ++++: High |
Liver steatosis assessed with: MRE | The mean liver steatosis ranged from -0.57% to -2.57% | MD 4.96 % lower (9.92 lower to 0.01 higher) | - | 138 (2 RCTs) | +++O: Moderate3 |
ALT | The mean ALT ranged from 1.90 U/L to -11.22 U/L | MD 14.06 U/L lower (22.06 lower to 6.07 lower) | - | 458 (3 RCTs) | ++++: High |
AST | The mean AST ranged from 1.50 U/K to -5.76 U/K | MD 11.44 U/K lower (17.23 lower to 5.65 lower) | - | 458 (3 RCTs) | ++++: High |
Serious adverse events | 109 per 1000 | 147 per 1000 (84 to 244) | OR 1.40 (0.75 to 2.62) | 456 (3 RCTs) | +++O: Moderate2,4 |
- Citation: Zhu K, Kakkar R, Chahal D, Yoshida EM, Hussaini T. Efficacy and safety of semaglutide in non-alcoholic fatty liver disease. World J Gastroenterol 2023; 29(37): 5327-5338
- URL: https://www.wjgnet.com/1007-9327/full/v29/i37/5327.htm
- DOI: https://dx.doi.org/10.3748/wjg.v29.i37.5327