Table 1.
Baseline demographics and clinical characteristics of participants receiving single ascending doses (a) or multiple ascending doses (b) of AMG 133 or placebo
| 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 |
Data are mean ± s.d. or number (%) of participants.
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.