Table 1.
Patient baseline characteristics
| Empty Cell | Empty Cell | Semaglutide 2·4 mg group (n=47) | Placebo group (n=24) |
|---|---|---|---|
| Sex | |||
| Female | 31 (66%) | 18 (75%) | |
| Male | 16 (34%) | 6 (25%) | |
| Age, years | 59·9 (7·1) | 58·7 (9·7) | |
| Ethnicity | |||
| American Indian/Alaska Native | 1 (2%) | 0 | |
| Asian | 1 (2%) | 0 | |
| Black/African American | 0 | 2 (8%) | |
| White | 41 (87%) | 21 (88%) | |
| Other | 1 (2%) | 0 | |
| Not reported | 3 (6%) | 1 (4%) | |
| Bodyweight, kg | 95·2 (18·7) | 98·6 (22·2) | |
| BMI, kg/m2 | 34·6 (5·9) | 35·5 (6·0) | |
| Type 2 diabetes | 35 (75%) | 18 (75%) | |
| HbA1c, % | 7·1 (1·3) | 7·2 (1·2) | |
| Lipids, mg/dL | |||
| LDL cholesterol | 100·0 (34·4) | 88·1 (41·7) | |
| HDL cholesterol | 44·7 (10·0) | 45·8 (12·6) | |
| VLDL cholesterol | 32·5 (17·4) | 29·6 (11·0) | |
| Total cholesterol | 177·2 (34·9) | 163·4 (47·5) | |
| Free fatty acids | 15·6 (7·9) | 15·9 (8·1) | |
| Triglycerides | 168·9 (98·3) | 151·6 (56·2) | |
| Blood pressure, mm Hg | |||
| Diastolic | 78·7 (9·6) | 87·0 (6·6) | |
| Systolic | 132·6 (13·7) | 135·8 (14·7) | |
| Steatosis | |||
| 1 | 32 (68%) | 15 (63%) | |
| 2 | 12 (26%) | 7 (29%) | |
| 3 | 3 (6%) | 2 (8%) | |
| Lobular inflammation | |||
| 1 | 14 (30%) | 6 (25%) | |
| 2 | 31 (66%) | 17 (71%) | |
| 3 | 2 (4%) | 1 (4%) | |
| Hepatocyte ballooning | |||
| 1 | 18 (38%) | 8 (33%) | |
| 2 | 29 (62%) | 16 (67%) | |
| Ishak score* | |||
| 4 | 0 (0%) | 1 (4%) | |
| 5 | 9 (19%) | 6 (25%) | |
| 6 | 38 (81%) | 17 (71%) | |
| Total NAFLD activity score | 4·7 (1·0) | 4·9 (1·2) | |
| Hepatic collagen proportion | 11·5 (7·3) | 9·4 (4·8) | |
| Imaging, geometric mean (CV) | |||
| MRE, kPa | 6·4 (27·9) | 5·8 (30·7) | |
| MRI-PDFF, % | 10·0 (58·3) | 10·4 (54·7) | |
| Liver enzymes, U/L, geometric mean (CV) | |||
| ALT | 47·6 (59·0) | 36·4 (57·3) | |
| AST | 47·2 (45·7) | 39·0 (46·0) | |
| GGT | 94·3 (85·1) | 95·0 (133·5) | |
| Exploratory biomarkers, geometric mean unless stated | |||
| ELF | 10·7 (0·8) | 10·6 (0·7) | |
| Pro-C3, ng/mL (CV) | 20·4 (31·3) | 17·9 (26·1) | |
| Pro-C3 N-terminal peptide, ng/mL | 21·5 (8·6) | 18·5 (5·3) | |
| FIB-4, score (CV) | 2·4 (38·3) | 2·2 (54·2) | |
| Total adiponectin, μg/mL (CV) | 3·3 (69·0) | 4·2 (94·9) | |
| TIMP-1, ng/mL | 340·3 (83·0) | 350·8 (106·7) | |
| Hyaluronic acid, ng/mL | 188·9 (156·5) | 154·9 (92·9) | |
| Liver severity | |||
| MELD score | 7·6 (1·2) | 7·7 (2·6) | |
| Child–Pugh classification | 5·0 (0·1) | 5·0 (0·0) | |
| Albumin, g/dL | 4·2 (0·3) | 4·2 (0·3) | |
| Bilirubin, mg/dL | 0·3 (0·1) | 0·3 (0·1) | |
| INR | 1·1 (0·1) | 1·1 (0·4) | |
| Sodium, mmol/L | 140·2 (2·3) | 139·7 (2·5) | |
| Thrombocytes, 109/L | 178·4 (50·5) | 183·5 (63·1) | |
Data are n (%) or mean (SD) unless otherwise stated. Data based on full analysis set. ALT=alanine aminotransferase. AST=aspartate aminotransferase. BMI=body-mass index. CV=coefficient of variance. ELF=enhanced liver fibrosis. FIB-4=fibrosis-4 index. GGT=gamma glutamyltransferase. INR=international normalised ratio. MRE=magnetic resonance elastography. MRI-PDFF=MRI proton density fat fraction. NAFLD=non-alcoholic fatty liver disease. Pro-C3=pro-collagen 3 peptide. TIMP-1=tissue inhibitor of metalloproteinase-1.
*
Ishak score was not one of the inclusion criteria for this study.