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

Variable	Placebo-treateda			Leptin-treated
	n	Mean ± SE	%	n	Mean ± SE	%	P valueb	P valuec
Female			42.9			42.0
BMI								0.80
Baseline	21	32.8 ± 0.7		50	32.7 ± 0.5		0.84
Week 4	21	32.6 ± 0.7		47	32.5 ± 0.5		0.85
Week 16	19	32.8 ± 0.7		45	31.9 ± 0.5		0.36
Change after 16 wk	19	−0.5 ± 0.2	−1.6	45	−0.7 ± 0.1	−2.1	0.43
Leptin (ng/mL)								<0.0001
Baseline	18	38.0 ± 6.4		48	35.2 ± 3.5		0.27
Week 4	18	35.5 ± 6.8		49	430.6 ± 47.4		<0.0001
Week 16	20	36.8 ± 6.5		48	987.1 ± 50.1		<0.0001
Change after 16 wk	18	−3.1 ± 3.2	−8.2	47	957.2 ± 50.4	2,721	<0.0001
LBP (ng/mL)								0.04
Baseline	20	25.3 ± 1.7		49	25.0 ± 1.2		0.88
Week 4	19	23.5 ± 1.4		49	24.4 ± 1.2		0.77
Week 16	21	22.7 ± 1.4		49	24.4 ± 1.1		0.35
Change after 16 wk	20	−2.2 ± 1.1	−8.8	48	−0.4 ± 0.5	−1.5	0.07
Free leptin (ng/mL)								0.002
Baseline	15	15.8 ± 3.3		32	22.6 ± 4.7		0.37
Week 4	7	13.9 ± 4.2		26	30.0 ± 6.0		0.16
Week 16	16	14.5 ± 3.9		33	61.6 ± 7.8		0.0002
Change after 16 wk	11	−1.3 ± 1.6	−8.1	21	53.2 ± 11.5	236.0	0.002
Antibody titer (µg/mL)								0.0009
Baseline	7	0.0 ± 0.0		16	5.3 ± 4.0		0.41
Week 4	1	0.0 ± 0.0		8	33.5 ± 11.4		0.56
Week 16	6	0.0 ± 0.0		14	52.3 ± 2.7		<0.0001
Change after 16 wk	4	0.0 ± 0.0	0	5	52.7 ± 3.9	987.4	0.0001
IL-6 (pg/mL)								0.62
Baseline	20	3.2 ± 0.2		49	3.7 ± 0.4		0.25
Week 4	19	3.7 ± 0.2		49	3.6 ± 0.5		0.78
Week 16	21	3.5 ± 0.3		49	3.6 ± 0.5		0.78
Change after 16 wk	20	−0.1 ± 0.6	−3.2	48	0.2 ± 0.3	6.4	0.59
CRP (µg/L)								0.93
Baseline	20	9,356 ± 2,059		48	9,138 ± 1,172		0.95
Week 4	19	9,200 ± 2,026		49	9,702 ± 1,215		0.87
Week 16	21	8,609 ± 2,013		49	9,512 ± 1,158		0.62
Change after 16 wk	20	−555 ± 1,013	−5.9	47	448 ± 883	4.9	0.52
sTNFR-I (pg/mL)								0.31
Baseline	20	1,058 ± 63.1		49	1,129 ± 45.7		0.43
Week 4	19	1,056 ± 68.0		50	1,147 ± 51.6		0.37
Week 16	21	1,051 ± 69.7		49	1,134 ± 48.2		0.29
Change after 16 wk	20	−8.6 ± 32.6	−0.8	48	23.7 ± 23.8	2.1	0.47
sTNFR-II (pg/mL)								0.09
Baseline	20	2,089 ± 186.9		49	2,470 ± 111.0		0.08
Week 4	19	2,132 ± 217.7		50	2,493 ± 118.1		0.14
Week 16	21	2,132 ± 172.1		49	2,533 ± 111.3		0.04
Change after 16 wk	20	−4.4 ± 63.9	−0.2	48	84.5 ± 57.1	3.4	0.39
sICAM-1 (ng/mL)								0.31
Baseline	20	298.4 ± 12.5		49	313.2 ± 14.1		0.54
Week 4	18	282.8 ± 13.0		48	305.6 ± 14.1		0.38
Week 16	21	288.6 ± 12.4		48	317.7 ± 14.0		0.20
Change after 16 wk	20	−7.0 ± 8.4	−2.3	47	−1.4 ± 9.8	−0.4	0.77
IL-10 (pg/mL)								0.42
Baseline	11	10.4 ± 2.0		27	8.9 ± 1.0		0.56
Week 4	9	9.2 ± 2.5		18	8.5 ± 1.1		0.91
Week 16	13	9.2 ± 1.6		25	9.2 ± 1.2		0.94
Change after 16 wk	8	0.2 ± 0.4	2.3	19	0.9 ± 1.2	10	0.71

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.