Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial

Table 2 Summary of treatment-emergent adverse events

Participants, n (%)	Healthy volunteers					Patients with T2DM
		Volixibat				Placebo	Volixibat
	Placebo (n = 12)	0.5 mg (n = 10)	1 mg (n = 9)	5 mg (n = 9)	10 mg (n = 9)	(n = 3)	10 mg (n = 8)
Any adverse event	10 (83.3)	7 (70.0)	9 (100)	8 (88.9)	9 (100)	1 (33.3)	7 (87.5)
Treatment-related adverse events	6 (50.0)	7 (70.0)	8 (88.9)	8 (88.9)	9 (100)	1 (33.3)	6 (75.0)
Severe adverse events	0	0	0	0	0	0	0
Serious adverse events	0	0	0	0	1 (11.1)^a	0	0
Deaths	0	0	0	0	0	0	0
Adverse events reported in >1 participant in any group^b
Gastrointestinal disorders
Diarrhoea	3 (25.0)	5 (50.0)	8 (88.9)	8 (88.9)	9 (100)	1 (33.3)	6 (75.0)
Abdominal pain	3 (25.0)	3 (30.0)	5 (55.6)	6 (66.7)	7 (77.8)	1 (33.3)	3 (37.5)
Gastrointestinal sounds abnormal	2 (16.7)	0	0	2 (22.2)	4 (44.4)	0	1 (12.5)
Nausea	2 (16.7)	1 (10.0)	1 (11.1)	1 (11.1)	4 (44.4)	0	0
Flatulence	0	1 (10.0)	2 (22.2)	0	4 (44.4)	1 (33.3)	0
Abdominal distension	1 (8.3)	2 (20.0)	1 (11.1)	0	2 (22.2)	0	0
Abdominal discomfort	1 (8.3)	1 (10.0)	2 (22.2)	0	0	0	0
Dry mouth	0	0	0	0	0	0	2 (25.0)
Nervous system disorders
Headache	4 (33.3)	2 (20.0)	3 (33.3)	1 (11.1)	3 (33.3)	0	1 (12.5)
Dizziness	1 (8.3)	0	0	0	2 (22.2)	0	1 (12.5)
General disorders and administration site conditions
Fatigue	1 (8.3)	0	2 (22.2)	1 (11.1)	0	0	0
Influenza-like illness	0	0	0	2 (22.2)	0	0	0
Infections and infestations
Rhinitis	2 (16.7)	1 (10.0)	0	1 (11.1)	0	0	1 (12.5)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	3 (25.0)	0	1 (11.1)	0	0	0	0
Musculoskeletal and connective tissue disorders
Pain in extremity	0	0	2 (22.2)	0	0	0	0

T2DM type 2 diabetes mellitus
Data are from the safety analysis set
^aAblation of the retina with a bleed in the vitreous body of the right eye (moderate severity), which was not considered to be related to the study drug by the principal investigator. ^bReported by System Organ Class in descending order of frequency in the volixibat 10 mg group for healthy volunteers

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