Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients

Table 2 Summary of patients achieved alanine aminotransferase normalization and improvements in the liver stiffness (using FibroScan) at week 12, n (%)

Visits	norUDCA group (n = 108)	Placebo group (n = 55)	P value
ALT normalization at week 12
Normalization	97 (89.8)	42 (76.4)	0.022
Abnormal	11 (10.2)	13 (23.6)
FibroScan stages at week 12
Improvement	62 (57.4)	22 (40.0)	0.035
No improvement	46 (42.6)	33 (34.5)

Normalization: Alanine aminotransferase ≤ 33 U/L for female and alanine aminotransferase ≤ 41 U/L for male; improvement: F2 to F0-F1; F3 to F0-F1; F3 to F2; No improvement: F2 to F2; F3 to F3. norUDCA: Norursodeoxycholic acid; ALT: Alanine aminotransferase.