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

Table 7 Summary of adverse events, n (%)

Adverse events	norUDCA 1500 mg (n = 108)	Placebo (n = 55)
Patients with at least one TEAE	34 (30.9)	12 (21.81)
Total number of adverse events	42 (38.2)	14 (25.4)
Adverse events
Abdominal bloating	1 (0.93)	0
Abdominal pain	1 (0.93)	0
Abrasion	1 (0.93)	0
Acidity	0	1 (0.02)
Body pain	1 (0.93)	0
Cold	1 (0.93)	0
Constipation	3 (2.78)	0
Cough	1 (0.93)	0
Diabetes (hyperglycaemia)	3 (2.78)	1 (0.02)
Dyslipidaemia	15 (13.89)	3 (5.5)
Elevated liver enzymes	1 (0.93)	0
Epigastric pain	1 (0.93)	0
Fever	2 (1.85)	1 (0.02)
Gastric irritation	2 (1.85)	0
Headache	2 (1.85)	1 (0.02)
Hyperglycemia (impaired fasting glucose)	0	1 (0.02)
Loose stool	0	1 (0.02)
Mild thrombocytopenia	0	1 (0.02)
Nausea	0	1 (0.02)
Raised bilirubin	1 (0.93)	0
Rhinitis	1 (0.93)	0
Thrombocytopenia	1 (0.93)	0
Type 2 diabetes mellitus	4 (3.70)	3 (0.05)

norUDCA: Norursodeoxycholic acid; TEAE: Treatment-emergent adverse events.