Table 2.
Comparison of study parameters at baseline and 12 months after metreleptin treatment in the PL study
| Parameters | n* | Baseline | Month 12 | P value |
|---|---|---|---|---|
| Body weight (kg) | 19 | 75.6 ± 21.8 | 75.0 ± 23.1 | 0.494 |
| Body mass index (kg/m2) | 19 | 26.8 ± 5.8 | 26.5 ± 6.3 | 0.270 |
| Waist-to-hip ratio | 19 | 1.00 ± 0.08 | 0.98 ± 0.08 | 0.079 |
| FMR (%fat trunk/ %fat legs) | 19 | 1.8 ± 0.5 | 1.7 ± 0.7 | 0.537 |
| Systolic blood pressure (mmHg) | 19 | 126 ± 16 | 128 ± 17 | 0.583 |
| Diastolic blood pressure (mmHg) | 19 | 74 ± 11 | 73 ± 12 | 0.653 |
| Hemoglobin A1c (%) | 19 | 8.9 ± 1.9 | 8.2 ± 1.9 | 0.077 |
| Glucose (mg/dL) | 19 | 193 ± 84 | 164 ± 67 | 0.055 |
| # Triglyceride (mg/dL) | 19 | 576 (327 – 1016) | 301 (206 – 441) | 0.014 |
| # AST (IU/L) | 19 | 42 ± 29 | 30 ± 14 | 0.043 |
| # ALT (IU/L) | 19 | 51 ± 33 | 36 ± 23 | 0.004 |
| REE (kcal) | 19 | 1851 ± 333 | 1719 ± 369 | 0.004 |
| RQ | 19 | 0.77 ± 0.07 | 0.75 ± 0.06 | 0.305 |
| Liver fat (Dixon MR method) (%) | 19 | 13 ± 7 | 8 ± 5 | 0.001 |
| NAS | 18 | 5 ± 1 | 4 ± 1 | < 0.001 |
| NASH score | 18 | 6 ± 2 | 5 ± 2 | 0.008 |
| **Total intake (grams) | 18 | 2791 ± 1141 | 2668 ± 675 | 0.809 |
| Total energy intake (kcal) | 18 | 1710 ± 412 | 1540 ± 531 | 0.253 |
| Total fat intake (grams) | 18 | 73 ± 26 | 64 ± 24 | 0.175 |
| Total carbohydrate intake (grams) | 18 | 184 ± 49 | 166 ± 74 | 0.372 |
| Total protein intake (grams) | 18 | 88 ± 18 | 84 ± 28 | 0.802 |
Number of participants with data available at baseline and 12 months for each outcome. Nineteen participants completed 1 year of metreleptin treatment and 18 completed a second liver biopsy. One subject did not complete the second biopsy due to use of anticoagulation. Energy intake was assessed in 18 subjects as one subject (patient 1) did not return baseline food records. ALT: alanine aminotransferase, AST: aspartate aminotransferase, FMR: fat mass ratio, REE: resting energy expenditure, RQ: respiratory quotient. NAS: non-alcoholic fatty liver disease activity score, the sum of scores for steatosis, lobular inflammation, and ballooning, NASH score: nonalcoholic steatohepatitis score equals the sum of scores for steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis.
Total intake includes food, water and other beverages. Levels are compared by using paired sample t-test.
Tests are run on log-transformed data. Data are presented as mean ± standard deviation (SD). Triglycerides are shown as geometric mean with 95% confidence intervals.