Table 2.
Comparative Biochemical Data of Both Groups at Baseline and Over Time
| Variable | Group | Baseline | Week 12 | Week 24 | Week 36 | P Value Within Groupsa |
|---|---|---|---|---|---|---|
| Leptin, ng/mL | Metreleptin | 4.4 ± 0.8 | 23.8 ± 5.1b,c | 30.1 ± 6.7b,c | 28.0 ± 6.3b,c | .001 |
| Placebo | 3.4 ± 0.6 | 3.2 ± 0.7 | 8.0 ± 2.9 | 4.8 ± 1.8 | .23 | |
| RANKL, pmol/L | Metreleptin | 303 ± 55 | 239 ± 36 | 268 ± 39 | 242 ± 25 | .18 |
| Placebo | 248 ± 34 | 236 ± 23 | 233 ± 24 | 251 ± 29 | .69 | |
| OPG, pmol/L | Metreleptin | 51.1 ± 3.6 | 53.2 ± 4.0 | 56.6 ± 3.8 | 56.3 ± 2.6 | .23 |
| Placebo | 49.8 ± 4.6 | 48.6 ± 7.2 | 48.7 ± 5.9 | 53.6 ± 4.1 | .61 | |
| RANKL to OPG ratio | Metreleptin | 6.6 ± 1.3 | 4.9 ± 0.9 | 5.1 ± 0.8 | 4.5 ± 0.6 | .04 |
| Placebo | 5.2 ± 0.9 | 5.6 ± 1.0 | 5.3 ± 0.9 | 4.8 ± 0.5 | .82 | |
| DKK-1, ng/mL | Metreleptin | 19.3 ± 2.8 | 20.5 ± 2.6 | 24.9 ± 2.2c | 18.8 ± 2.3 | .34 |
| Placebo | 14.6 ± 2.9 | 15.8 ± 2.2 | 17.0 ± 2.9 | 16.2 ± 2.2 | .76 | |
| Sclerostin, ng/mL | Metreleptin | 0.433 ± 0.049 | 0.333 ± 0.031 | 0.355 ± 0.043 | 0.450 ± 0.059 | .07 |
| Placebo | 0.396 ± 0.052 | 0.352 ± 0.028 | 0.308 ± 0.038 | 0.432 ± 0.065 | .23 | |
| FGF23, U/mL | Metreleptin | 56.4 ± 12.7 | 64.1 ± 11.8 | 45.6 ± 8.6 | 42.1 ± 7.8 | .32 |
| Placebo | 54.8 ± 9.5 | 61.3 ± 15.5 | 55.9 ± 11.0 | 75.8 ± 17.3 | .55 | |
| iPTH, pg/mL | Metreleptin | 41.8 ± 6.3 | 42.8 ± 4.5 | 34.4 ± 3.6 | 26.7 ± 2.6b,d | .01 |
| Placebo | 29.1 ± 3.1 | 32.2 ± 2.7 | 35.7 ± 5.4 | 30.4 ± 3.6 | .59 | |
| 25-Hydroxyitamin D, μg/dL | Metreleptin | 20.9 ± 2.7 | 25.7 ± 2.4 | 24.0 ± 2.8 | 20.8 ± 2.4 | .40 |
| Placebo | 26.4 ± 3.6 | 23.1 ± 3.5 | 21.0 ± 3.3 | 24.2 ± 2.3 | .35 | |
| Corrected calcium, mg/dL | Metreleptin | 7.8 ± 0.4 | 8.8 ± 0.2 | 8.6 ± 0.1 | 8.3 ± 0.3 | .12 |
| Placebo | 8.4 ± 0.9 | 9.0 ± 1.0 | 7.6 ± 0.7 | 7.9 ± 0.7 | .73 | |
| Phosphate, mg/dL | Metreleptin | 4.2 ± 0.1 | 4.4 ± 0.2 | 4.3 ± 0.2 | 4.5 ± 0.2 | .69 |
| Placebo | 4.3 ± 0.2 | 4.0 ± 0.1 | 4.2 ± 0.2 | 4.1 ± 0.1 | .49 | |
| Creatinine, mg/dL | Metreleptin | 0.84 ± 0.03 | 0.79 ± 0.04 | 0.71 ± 0.06 | 0.80 ± 0.03 | .13 |
| Placebo | 0.86 ± 0.05 | 0.93 ± 0.10 | 0.74 ± 0.05 | 0.81 ± 0.02 | .13 |
Data are presented as mean ± SEM.
a
Within-group comparisons are repeated-measures ANOVA or Friedman's test; pairwise comparisons are Bonferroni post hoc test.
b
P < .05 compared with baseline.
c
P < .05 for between-group comparisons (Mann-Whitney test).
d
P < .05 compared with week 12.
e
P < .05 compared with week 24.