Table 1 Baseline demographics and clinical characteristics of participants receiving single ascending doses (a) or multiple ascending doses (b) of AMG 133 or placebo

From: A GIPR antagonist conjugated to GLP-1 analogues promotes weight loss with improved metabolic parameters in preclinical and phase 1 settings

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)

Age (years)

45.7 ± 13.4

53.8 ± 9.5

47.8 ± 12.9

48.0 ± 11.9

45.5 ± 11.6

50.2 ± 7.2

45.7 ± 13.7

Males

8 (66.7)

1 (16.7)

5 (83.3)

4 (57.1)

4 (66.7)

5 (83.3)

5 (83.3)

Race

 American Indian or Alaska Native

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

1 (16.7)

0 (0.0)

 Asian

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

1 (16.7)

 Black (or African American)

4 (33.3)

2 (33.3)

2 (33.3)

5 (71.4)

3 (50.0)

0 (0.0)

0 (0.0)

 White

8 (66.7)

4 (66.7)

4 (66.7)

2 (28.6)

3 (50.0)

5 (83.3)

5 (83.3)

Weight (kg)

97.2 ± 12.4

94.9 ± 11.0

104.5 ± 13.0

95.5 ± 14.5

101.4 ± 9.7

107.4 ± 21.0

98.8 ± 13.5

BMI (kg m−2)

32.8 ± 2.1

33.8 ± 2.6

32.5 ± 4.0

33.9 ± 1.8

34.8 ± 4.0

34.3 ± 3.6

32.5 ± 2.3

HbA1c (%)

5.38 ± 0.35

5.62 ± 0.22

5.45 ± 0.41

5.61 ± 0.48

5.40 ± 0.74

5.48 ± 0.26

5.57 ± 0.27

b

 

Placebo (n = 6)

140 mg (n = 6)

280 mg (n = 6)

420 mg (n = 8)

Age (years)

45.7 ± 14.0

40.3 ± 16.6

44.5 ± 13.8

51.6 ± 12.8

Males

2 (33.3)

5 (83.3)

4 (66.7)

1 (12.5)

Race

 American Indian or Alaska Native

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 Asian

0 (0.0)

1 (16.7)

0 (0.0)

0 (0.0)

 Black (or African American)

1 (16.7)

3 (50.0)

1 (16.7)

1 (12.5)

 White

5 (83.3)

2 (33.3)

5 (83.3)

7 (87.5)

Weight (kg)

98.9 ± 15.8

101.5 ± 8.3

98.7 ± 16.5

90.5 ± 10.3

BMI (kg m−2)

34.2 ± 3.7

34.1 ± 2.9

33.4 ± 3.6

32.5 ± 2.6

Waist circumference (cm)

108.1 ± 16.7

105.2 ± 10.0

106.2 ± 20.9

102.4 ± 10.8

HbA1c (%)

5.50 ± 0.20

5.60 ± 0.48

5.57 ± 0.33

5.58 ± 0.27

  1. Data are mean ± s.d. or number (%) of participants.
  2. For the SAD cohorts (a), a 70 mg i.v. cohort (n = 8) to determine bioavailability was not included. For the MAD cohorts (b), one cohort (280 mg × 3; n = 13) to evaluate digital tools was not included. Two open-label cohorts (final dose level did not exceed 420 mg, n = 14) to evaluate titration were not included.