TABLE 1.
Baseline characteristics by diabetes status.
| Pooled data | |||||||
|---|---|---|---|---|---|---|---|
| Treatment group | Semaglutide (n = 163) | Placebo (n = 137) | |||||
| Baseline T2D status | Non‐T2D (n = 21) | Pre‐T2D (n = 25) | T2D (n = 117) | Non‐T2D (n = 19) | Pre‐T2D (n = 26) | T2D (n = 92) | Total (n = 300) |
| Age, years | 57.1 (9.7) | 54.4 (9.6) | 57.5 (9.8) | 49.3 (10.2) | 53.8 (11.7) | 57.2 (10.0) | 56.3 (10.2) |
| Female sex | 10 (47.6) | 16 (64.0) | 63 (53.8) | 11 (13.9) | 10 (38.5) | 50 (54.3) | 160 (53.3) |
| Ethnicity | |||||||
| Hispanic or Latino | 2 (9.5) | 8 (32.0) | 15 (12.8) | 2 (10.5) | 2 (7.7) | 9 (9.8) | 38 (12.7) |
| Non‐Hispanic or Latino | 15 (71.4) | 17 (68.0) | 100 (85.5) | 16 (84.2) | 21 (80.8) | 81 (88.0) | 250 (83.3) |
| Body weight, kg | 94.7 (22.4) | 97.0 (20.0) | 98.8 (18.3) | 97.3 (19.6) | 104.1 (21.8) | 101.0 (21.1) | 99.4 (19.9) |
| BMI, kg/m2 | 33.9 (6.7) | 35.5 (6.3) | 35.0 (5.5) | 34.5 (5.9) | 34.4 (5.2) | 36.0 (6.0) | 35.2 (5.8) |
| Waist circumference, cm | 109.5 (14.7) | 112.2 (11.9) | 114.2 (11.9) | 110.0 (11.3) | 115.6 (12.7) | 117.0 (15.0) | 114.4 (13.3) |
| Biopsy‐confirmed MASH a | 19 (90.5) | 23 (92.0) | 87 (74.4) | 15 (78.9) | 18 (69.2) | 71 (77.2) | 233 (77.7) |
| Fibrosis stage a | |||||||
| Not assessed | 2 (9.5) | 2 (8.0) | 30 (25.6) | 4 (21.1) | 8 (30.8) | 21 (22.8) | 67 (22.3) |
| F1 | 4 (19.0) | 6 (24.0) | 16 (13.7) | 5 (26.3) | 5 (19.2) | 12 (13.0) | 48 (16.0) |
| F2 | 3 (14.3) | 4 (16.0) | 7 (6.0) | 2 (10.5) | 5 (19.2) | 15 (16.3) | 36 (12.0) |
| F3 | 7 (33.3) | 6 (24.0) | 29 (24.8) | 5 (26.3) | 6 (23.1) | 25 (26.3) | 78 (26.0) |
| F4 | 5 (23.8) | 7 (28.0) | 35 (30.0) | 3 (15.8) | 2 (7.7) | 19 (20.7) | 71 (23.7) |
| Known diabetes duration, years b | ‐ | ‐ | 8.4 (7.0) | ‐ | ‐ | 9.2 (7.2) | 8.8 (7.1) |
| HbA1c, % | 5.5 (0.2) | 5.9 (0.2) | 7.3 (1.1) | 5.3 (0.3) | 6.0 (0.2) | 7.4 (1.1) | 6.8 (1.2) |
| HbA1c, mmol/mol | 37 | 41 | 56 | 34 | 42 | 57 | 51 |
| HDL cholesterol, mmol/L | 1.1 (0.2) | 1.2 (0.3) | 1.1 (0.3) | 1.4 (0.3) | 1.1 (0.3) | 1.1 (0.3) | 1.14 (0.3) |
| LDL cholesterol, mmol/L | 3.1 (1.1) | 3.4 (1.1) | 2.7 (1.0) | 3.2 (0.8) | 3.1 (1.1) | 2.9 (1.0) | 2.91 (1.0) |
| Triglycerides, mmol/L | 1.7 (0.7) | 1.8 (1.1) | 2.2 (1.6) | 1.6 (0.8) | 2.3 (1.4) | 2.3 (1.5) | 2.12 (1.4) |
| Triglycerides/HDL | 1.6 (0.9) | 1.7 (1.2) | 2.3 (3.0) | 1.3 (0.8) | 2.2 (2.0) | 2.6 (3.1) | 2.2 (2.6) |
| Triglycerides/LDL | 0.6 (0.3) | 0.5 (0.3) | 1.3 (3.7) | 0.5 (0.2) | 1.0 (1.5) | 0.9 (0.5) | 1.0 (2.3) |
| ALT, U/L, Gmean (CV) | 48.0 (55.0) | 57.2 (53.4) | 47.5 (62.5) | 53.3 (61.5) | 48.2 (65.7) | 44.0 (67.5) | 47.6 (63.1) |
| AST, U/L, Gmean (CV) | 39.3 (40.3) | 48.8 (40.0) | 40.7 (53.0) | 40.8 (48.5) | 36.1 (50.5) | 37.7 (54.4) | 39.9 (51.4) |
Note: Data are mean (standard deviation) or n (%) unless otherwise stated.
Abbreviations: ALT, alanine transaminase; AST, aspartate aminotransferase; BMI, body mass index; CV, coefficient of variation; Gmean, geometric mean; HbA1c, glycated haemoglobin; HDL, high‐density lipoprotein; LDL, low‐density lipoprotein; MASH, metabolic dysfunction‐associated steatohepatitis; Non‐T2D, no type 2 diabetes; Pre‐T2D, pre‐type 2 diabetes; T2D, type 2 diabetes.
a
Data only available for studies NCT02970942 and NCT03987451.
b
People with diabetes only.