TABLE 1

Clinical study I: Study variables for obese, diabetic subjects taking placebo (n = 21) or metreleptin (n = 50) at baseline and 4 and 16 weeks of follow-up and % change in study variables from baseline to 16 weeks

VariablePlacebo-treatedaLeptin-treated
nMean ± SE%nMean ± SE%P valuebP valuec
Female42.942.0
BMI0.80
 Baseline2132.8 ± 0.75032.7 ± 0.50.84
 Week 42132.6 ± 0.74732.5 ± 0.50.85
 Week 161932.8 ± 0.74531.9 ± 0.50.36
 Change after 16 wk19−0.5 ± 0.2−1.645−0.7 ± 0.1−2.10.43
Leptin (ng/mL)<0.0001
 Baseline1838.0 ± 6.44835.2 ± 3.50.27
 Week 41835.5 ± 6.849430.6 ± 47.4<0.0001
 Week 162036.8 ± 6.548987.1 ± 50.1<0.0001
 Change after 16 wk18−3.1 ± 3.2−8.247957.2 ± 50.42,721<0.0001
LBP (ng/mL)0.04
 Baseline2025.3 ± 1.74925.0 ± 1.20.88
 Week 41923.5 ± 1.44924.4 ± 1.20.77
 Week 162122.7 ± 1.44924.4 ± 1.10.35
 Change after 16 wk20−2.2 ± 1.1−8.848−0.4 ± 0.5−1.50.07
Free leptin (ng/mL)0.002
 Baseline1515.8 ± 3.33222.6 ± 4.70.37
 Week 4713.9 ± 4.22630.0 ± 6.00.16
 Week 161614.5 ± 3.93361.6 ± 7.80.0002
 Change after 16 wk11−1.3 ± 1.6−8.12153.2 ± 11.5236.00.002
Antibody titer (µg/mL)0.0009
 Baseline70.0 ± 0.0165.3 ± 4.00.41
 Week 410.0 ± 0.0833.5 ± 11.40.56
 Week 1660.0 ± 0.01452.3 ± 2.7<0.0001
 Change after 16 wk40.0 ± 0.00552.7 ± 3.9987.40.0001
IL-6 (pg/mL)0.62
 Baseline203.2 ± 0.2493.7 ± 0.40.25
 Week 4193.7 ± 0.2493.6 ± 0.50.78
 Week 16213.5 ± 0.3493.6 ± 0.50.78
 Change after 16 wk20−0.1 ± 0.6−3.2480.2 ± 0.36.40.59
CRP (µg/L)0.93
 Baseline209,356 ± 2,059489,138 ± 1,1720.95
 Week 4199,200 ± 2,026499,702 ± 1,2150.87
 Week 16218,609 ± 2,013499,512 ± 1,1580.62
 Change after 16 wk20−555 ± 1,013−5.947448 ± 8834.90.52
sTNFR-I (pg/mL)0.31
 Baseline201,058 ± 63.1491,129 ± 45.70.43
 Week 4191,056 ± 68.0501,147 ± 51.60.37
 Week 16211,051 ± 69.7491,134 ± 48.20.29
 Change after 16 wk20−8.6 ± 32.6−0.84823.7 ± 23.82.10.47
sTNFR-II (pg/mL)0.09
 Baseline202,089 ± 186.9492,470 ± 111.00.08
 Week 4192,132 ± 217.7502,493 ± 118.10.14
 Week 16212,132 ± 172.1492,533 ± 111.30.04
 Change after 16 wk20−4.4 ± 63.9−0.24884.5 ± 57.13.40.39
sICAM-1 (ng/mL)0.31
 Baseline20298.4 ± 12.549313.2 ± 14.10.54
 Week 418282.8 ± 13.048305.6 ± 14.10.38
 Week 1621288.6 ± 12.448317.7 ± 14.00.20
 Change after 16 wk20−7.0 ± 8.4−2.347−1.4 ± 9.8−0.40.77
IL-10 (pg/mL)0.42
 Baseline1110.4 ± 2.0278.9 ± 1.00.56
 Week 499.2 ± 2.5188.5 ± 1.10.91
 Week 16139.2 ± 1.6259.2 ± 1.20.94
 Change after 16 wk80.2 ± 0.42.3190.9 ± 1.2100.71
  • sICAM, soluble intracellular adhesive molecule.

  • aData presented are on treatment. The number of subjects is variable because of occasional missing blood test results from a few subjects in a small numbers of analytes as shown. The change after 16 weeks is based on pairwise difference of subjects who had data available for both baseline and week 16 time points. Means ± SEs are presented for each variable at each follow-up visit.

  • bP values are calculated from one-way ANOVA.

  • cP values are calculated from repeated-measures analysis evaluating the change in study variables over time, adjusted for age and sex.