Skip to main content
. 2024 Feb 5;6(2):290–303. doi: 10.1038/s42255-023-00966-w

Table 2.

Gastrointestinal-related treatment-emergent adverse events in humans after a single dose (a) or multiple ascending doses (b) of placebo and AMG 133

a
Placebo (n = 12) 21 mg (n = 6) 70 mg (n = 6) 140 mg (n = 7) 280 mg (n = 6) 560 mg (n = 6) 840 mg (n = 6)
Number of individuals reporting TEAEs 3 (25.0) 0 (0.0) 2 (33.3) 5 (71.4) 6 (100.0) 5 (83.3) 6 (100.0)
GI disorders
 Diarrhoea 2 (16.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Dyspepsia 1 (8.3) 0 (0.0) 1 (16.7) 4 (57.1) 0 (0.0) 0 (0.0) 0 (0.0)
 Abdominal discomfort 0 (0.0) 0 (0.0) 0 (0.0) 2 (28.6) 0 (0.0) 0 (0.0) 0 (0.0)
 Constipation 1 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 0 (0.0) 3 (50.0)
 Gastroesophageal reflux disease 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0)
 Nausea 3 (25.0) 0 (0.0) 2 (33.3) 4 (57.1) 4 (66.7) 5 (83.3) 5 (83.3)
 Vomiting 0 (0.0) 0 (0.0) 1 (16.7) 4 (57.1) 5 (83.3) 5 (83.3) 4 (66.7)
GI safety laboratory
 Amylase elevation 0 (0.0) 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0)
 Lipase elevation 0 (0.0) 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0)
 Hepatic enzyme elevation 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0)
b
Placebo (n = 6) 140 mg (n = 6) 280 mg (n = 6) 420 mg (n = 8)
Number of individuals reporting TEAEs 3 (50.0) 6 (100.0) 6 (100.0) 8 (100.0)
GI disorders
 Diarrhoea 0 (0.0) 1 (16.7) 0 (0.0) 2 (25.0)
 Dyspepsia 0 (0.0) 1 (16.7) 0 (0.0) 1 (12.5)
 Abdominal distension 0 (0.0) 1 (16.7) 0 (0.0) 1 (12.5)
 Abdominal pain upper 0 (0.0) 0 (0.0) 0 (0.0) 1 (12.5)
 Constipation 0 (0.0) 2 (33.3) 1 (16.7) 0 (0.0)
 Nausea 1 (16.7) 5 (83.3) 4 (66.7) 8 (100.0)
 Vomiting 0 (0.0) 4 (66.7) 5 (83.3) 6 (75.0)
GI safety laboratory
 Amylase elevation 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0)
 Lipase elevation 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0)

Data show number (%) of participants with the event of interest.