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Table 5 Primary clinical outcomes of 158 phase I-IV NAFLD interventional clinical trials

From: Analyzing MASLD interventional clinical trial registration based on the ClinicalTrials.gov database

Outcome

Early phase1 (n = 2)

Phase 1 (n = 15)

Phase 1/2(n = 9)

Phase 2 (n = 128)

Phase 2/3(n = 4)

Phase 3 (n = 16)

Phase 4 (n = 9)

NA (n = 7)

total (n = 190)

Liver Histology

  

3 (33.33%)

26 (20.31%)

2 (50.00%)

6 (37.50%)

3 (33.33%)

 

40 (21.05%)

Safety and Adverse Events (AEs)

 

6 (40.00%)

2 (22.22%)

25 (19.53%)

 

1 (6.25%)

  

34 (17.89%)

Liver Enzymes

  

1 (11.11%)

13 (10.16%)

1 (25.00%)

1 (6.25%)

2 (22.22%)

1 (14.29%)

19 (10.00%)

Liver Fat

2 (100.00%)

2 (13.33%)

1 (11.11%)

35 (27.34%)

  

3 (33.33%)

2 (28.57%)

45 (23.68%)

HbA1c

   

4 (3.13%)

    

4 (2.11%)

Blood Glucose

   

1 (0.78%)

    

1 (0.53%)

Bone Mineral Density

   

1 (0.78%)

    

1 (0.53%)

Pharmacokinetic (PK) Parameter

 

7 (46.67%)

1 (11.11%)

7 (5.47%)

 

1 (6.25%)

  

16 (8.42%)

Liver/Spleen Ratio

       

2 (28.57%)

2 (1.05%)

Insulin Resistance

   

3 (2.34%)

  

1 (11.11%)

2 (28.57%)

6 (3.16%)

Low Density Lipoproteins (LDL)

   

3 (2.34%)

    

3 (1.58%)

Platelet Transfusion

     

1 (6.25%)

  

1 (0.53%)

Comprehensive Outcome

     

3 (18.75%)

  

3 (1.58%)

Triglyceride

  

1 (11.11%)

6 (4.69%)

    

7 (3.68%)

Hepatic Venous Pressure Gradient (HVPG)

   

3 (2.34%)

    

3 (1.58%)

Survival rate

    

1 (25.00%)

2 (12.50%)

  

3 (1.58%)

Liver Stiffness

   

1 (0.78%)

 

1 (6.25%)

  

2 (1.05%)

  1. Some trials had more than one primary clinical outcome. NA: Not applicable
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BMC Gastroenterology

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