APPENDIX TABLE 2.

EFFECTS OF TREATMENT ON BODY COMPOSITION

			BASELINE			6 MONTHS				12 MONTHS
BODY COMPOSITION			Mean (SD)	minimum-maximum		Mean Change ^*	95% CI	P Value MK-677 vs. Placebo ^†		Mean Change ^*	95% CI	P Value MK-677 vs. Placebo ^†
Primary Endpoints
FFM, kg [4-C]	Placebo		47.9 (11.9)	33.5-77.5		-0.2	-1.0 - 0.7			-0.4	-1.1 - 0.4
	MK-677	N=42	47.6 (9.9)	33.6-69.3	N=42	1.1	0.5 - 1.8	0.014	N=42	1.3	0.7 - 1.8	0.001
FFM, kg [DXA]	Placebo		48.2 (12.4)	34.3-76.5		-0.2	-0.9 - 0.5			-0.5	-1.1 - 0.2
	MK-677		48.3 (11.3)	30.8-71.2		1.0	0.5 - 1.5	0.006		1.1	0.7 - 1.5	<0.001
AVF, cm² [CT]	Placebo	N=18	104.8 (46.7)	35.6-214.0	N=18	6.0	-5.9 - 17.8		N=18	4.2	-6.2 - 14.5
	MK-677	N=41	128.8 (58.0)	36.7-313.9	N=41	2.5	-5.4 - 10.3	0.83	N=41	8.4	1.6 - 15.3	0.68
Other Endpoints
Weight, kg	Placebo		74.5 (13.7)	51.5-97.9		0.7	-0.5-1.9			0.8	-0.3 - 1.8
	MK-677		75.2 (11.1)	53.5-107.5		3.1	2.2 - 3.9	0.001		2.7	2.0 - 3.5	0.003
TBF, kg [4-C]	Placebo		26.6 (8.9)	12.0-49.2		0.9	-0.4 - 2.2			1.1	0.0 - 2.3
	MK-677	N=42	27.7 (7.0)	10.9-45.7	N=42	1.8	0.9 - 2.8	0.37	N=42	1.4	0.6 - 2.2	0.76
TBF, kg [DXA]	Placebo		26.1 (9.2)	11.6-49.7		0.9	0.0 - 1.9			1.1	0.2 - 1.9
	MK-677		26.5 (7.6)	7.5-44.9		2.1	1.4 - 2.8	0.040		1.8	1.2 - 2.5	0.130
Fat, % [4-C]	Placebo		35.7 (9.5)	19.0-53.2		0.8	-0.4 - 2.1			1.3	0.2 - 2.4
	MK-677	N=42	36.9 (7.9)	14.7-50.8	N=42	0.9	0.0 - 1.8	>.99	N=42	0.4	-0.4 - 1.2	0.196
Fat, % [DXA]	Placebo		35.2 (10.3)	19.4-53.8		0.9	0.1 - 1.8			1.2	0.4 - 0.9
	MK-677		35.7 (9.5)	9.8-49.9		1.1	0.5 - 1.7	>.99		0.8	0.3 - 1.3	0.39
Other Endpoints
ASCF, cm² [CT]	Placebo	N=18	281.2 - 124.2)	110.6-620.7	N=18	8.3	-7.5 - 24.1		N=18	1.3	-12.5 - 15.0
	MK-677	N=40	292.8 (97.0)	53-506.8	N=40	22.0	11.4 - 32.6	0.23	N=40	18.0	8.7 - 27.2	0.054
Limb Fat, kg [DXA]	Placebo		12.5 (4.6)	6.2-23.3		0.24	-0.2 - 0.7			0.29	-0.1 - 0.7
	MK-677		12.53 (4.1)	3.3-20.7		1.1	0.7 - 1.4	0.001		0.9	0.6 - 1.2	0.011
Limb Lean, kg [DXA]	Placebo		18.2 (6.0)	11.8-32.6		-0.17	-0.6 - 0.2			-0.3	-0.6 - 0.1
	MK-677		18.2 (5.4)	10.6-30.1		0.5	0.2 - 0.8	0.008		0.5	0.3 - 0.8	<0.001
T-Score for TASM/ht²	Placebo		-0.1 (1.4)	-2.5 - 2.4		-0.11	-0.32 - 0.11			-0.13	-0.32 - 0.06
	MK-677		-0.2 (1.1)	-2.4 - 2.5		0.26	0.10 - 0.41	0.005		0.29	0.16 - 0.42	<0.001
Thigh Muscle Area, cm² [CT]	Placebo		112.9 (33.3)	75.3-175.4	N=21	1.5	-1.7 - 4.7			-0.5	-3.2 - 2.2
	MK-677	N=41	111.2 (26.9)	78.3-185.4	N=41	2.6	0.3 - 4.9	>.99	N=41	1.5	-0.5 - 3.5	0.20
Leg Lean, kg [DXA]	Placebo		13.8 (4.1)	9.3-23.7		-0.11	-0.4 - 0.2			-0.25	-0.5 - 0.0
	MK-677		13.7 (3.7)	9.3-21.0		0.4	0.2 - 0.6	0.011		0.4	0.2 - 0.6	0.001
Arm Lean, kg [DXA]	Placebo		4.5 (2.0)	2.4-8.8		-0.1	-0.2 - 0.1			0.0	-0.2 - 0.1
	MK-677		4.5 (1.8)	2.3-9.1		0.09	0.0 - 0.2	0.104		0.16	0.1 - 0.3	0.019

Baseline data presented are arithmetic mean (SD) and the minimum and maximum values; Placebo (N=22) and MK-677 (N=43) unless otherwise indicated.

Mean change (arithmetic difference) from baseline with 95% confidence limits

^†

P values are for the pivotal comparisons between the two groups at 6 months and at 12 months.

FFM (fat-free mass) and TBF (total body fat) were measured by a 4-compartment (4-C) model and by DXA (dual energy x-ray absorptiometry)

AVF (abdominal visceral fat) and ASCF (abdominal subcutaneous fat) measured from a single-slice CT (computed tomography) scan

Limb fat (appendicular fat mass) from DXA, measured as the sum of the fat for the arms and the legs

Limb lean (total appendicular skeletal muscle mass; TASM) from DXA, measured as the sum of the lean soft tissue for the arms (arm lean) and the legs (leg lean)

Thigh muscle area (average of R and L thighs) from a single-slice CT scan

A t-score was computed for each individual, relating the TASM/ht² to those of gender-concordant young adults.