Table 1.
Baseline demographics and disease characteristics.
| Parameter | Placebo (n = 10) | Efruxifermin (n = 20) |
|---|---|---|
| Mean age, years (SD) | 57.1 (14.4) | 61.1 (10.0) |
| Sex, n (%) | ||
| Male | 7 (70.0) | 4 (20.0) |
| Female | 3 (30.0) | 16 (80.0) |
| Race or ethnicity, n (%) | ||
| White | 10 (100.0) | 18 (90.0) |
| Black or African American | 0 | 1 (5.0) |
| Native Hawaiian or other Pacific Islander | 0 | 1 (5.0) |
| Hispanic or Latino | 5 (50.0) | 8 (40.0) |
| Metabolic risk factors and parameters, mean (SD) | ||
| Body weight, kg | 119.1 (30.5) | 97.9 (19.8) |
| Body mass index, kg/m2 | 39.1 (8.2) | 36.0 (5.6) |
| Type 2 diabetes, n (%) | 5 (50.0) | 10 (50.0) |
| Markers of liver health, mean (SD) | ||
| Alanine aminotransferase, U/L | 32.7 (20.0) | 31.7 (16.8) |
| Aspartate aminotransferase, U/L | 28.9 (21.1) | 31.4 (13.7) |
| Gamma-glutamyltransferase, U/L | 46.7 (17.7) | 75.8 (39.2) |
| Alkaline phosphatase, U/L | 67.2 (19.0) | 77.9 (24.6) |
| Urate, mg/dl | 5.9 (1.4) | 6.0 (1.2) |
| High-sensitivity C-reactive protein, mg/L | 4.9 (5.8) | 6.7 (8.4) |
| Liver steatosis, CAP score, dB/m | 336.9 (48.5) | 299.2 (59.3) |
| Markers of fibrosis, mean (SD) | ||
| Pro-C3, μg/L | 22.6 (11.8) | 25.6 (27.5) |
| ELF score | 9.7 (0.8) | 10.4 (1.2) |
| Liver stiffness, kPA | 25.8 (13.2) | 22.1 (10.8) |
| Markers of liver function, mean (SD) | ||
| Bilirubin, mg/dl | 0.8 (0.2) | 0.7 (0.3) |
| Albumin, g/dl | 4.3 (0.2) | 4.2 (0.3) |
| Platelets, 10ˆ9/L | 166.8 (29.5) | 191.7 (34.5) |
| Fibrinogen, mg/dl | 407.0 (93.7) | 452.2 (64.6) |
| International normalized ratio | 1.1 (0.1) | 1.1 (0.1) |
| Plasminogen activator inhibitor-1, IU/ml | 14.0 (11.8) | 14.5 (10.6) |
| Model for end-stage liver disease score | 6.9 (0.9) | 7.4 (1.0) |
| Child-Pugh score | 5.0 (0.0) | 5.1 (0.2) |
| NAFLD activity score, mean (SD) | 3.3 (2.1) | 4.1 (1.7) |
| Markers of lipid metabolism, mean (SD) | ||
| Total cholesterol, mg/dl | 157.1 (42.9) | 167.4 (40.4) |
| Triglycerides, mg/dl | 121.7 (59.6) | 134.6 (62.8) |
| LDL-C, mg/dl | 89.5 (34.7) | 90.1 (34.4) |
| HDL-C, mg/dl | 43.3 (12.4) | 50.4 (13.8) |
| Non-HDL-C, mg/dl | 113.8 (43.3) | 117.1 (41.2) |
| Apolipoprotein B, mg/dl | 82.8 (26.1) | 82.6 (26.5) |
| Apolipoprotein C-III, mg/dl | 6.3 (3.3) | 7.8 (4.0) |
| Lipoprotein-a (nmol/L) | 48.7 (71.9) | 61.9 (66.7) |
| Beta -hydroxybutyrate (mmol/L) | 0.1 (0.1) | 0.1 (0.1) |
| Bile acids (μmol/L) | 10.3 (6.7) | 9.5 (8.8) |
| Markers of glycemic control, mean (SD) | ||
| Fasting serum glucose, mg/dl | 122.9 (26.4) | 107.3 (16.4) |
| HbA1c, % | 6.6 (1.4) | 6.1 (1.0) |
| Patients with type 2 diabetes | 7.3 (1.6), n = 5 | 6.5 (1.1), n = 10 |
| Patients without type 2 diabetes | 5.8 (0.7), n = 4 | 5.7 (0.5), n = 9 |
| C-peptide, μg/L | 5.7 (2.1) | 5.1 (1.0) |
| Insulin, mIU/L | 38.7 (21.9) | 29.4 (9.3) |
| HOMA-IR | 12.5 (8.1) | 8.4 (3.7) |
| Adiponectin, mg/L | 4.8 (2.5) | 5.8 (2.9) |
| Concomitant medications of interest, n (%) | ||
| Statins | 3 (30.0) | 6 (30.0) |
| GLP-1 receptor agonists | 3 (30.0) | 3 (15.0) |
CAP, controlled attenuation parameter; HOMA-IR, homeostatic model assessment of insulin resistance.