Table 2.

Mean changes in body weight and other parameters from baseline to week 4, week 8, and week 12, respectively

Parameters	104HD (n = 34)	104LD (n = 33)	Placebo (n = 33)	p value (104HD vs. placebo)	p value (104LD vs. placebo)
Body weight change, kg
Week 4	1.58±1.03	1.59±1.37	0.39±1.50	0.001	0.002
Week 8	2.96±1.52	2.38±2.07	1.16±1.87	<0.001	0.018
Week 12	4.96±1.89	3.70±2.57	1.33±2.05	<0.001	<0.001
BMI change, kg/m2
Week 4	0.55±0.37	0.53±0.44	0.13±0.50	0.001	0.003
Week 8	1.03±0.55	0.80±0.67	0.39±0.64	<0.001	0.024
Week 12	1.73±0.68	1.25±0.85	0.45±0.69	<0.001	<0.001
Waist circumference change, cm
Week 4	1.56±1.02	1.30±0.85	0.27±1.10	<0.001	<0.001
Week 8	2.91±1.36	2.21±1.32	0.70±1.16	<0.001	<0.001
Week 12	4.44±2.48	3.55±1.75	0.94±1.20	<0.001	<0.001
Hip circumference change, cm
Week 4	1.03±0.90	1.36±1.78	0.61±1.90	0.004	0.001
Week 8	2.29±1.45	2.00±1.80	0.64±1.17	<0.001	<0.001
Week 12	3.53±1.78	3.03±2.13	0.73±1.21	<0.001	<0.001
Body fat mass change, kg
Week 4	1.96±4.42	0.97±1.38	0.38±1.85	0.057	0.129
Week 8	2.86±3.58	1.53±1.92	0.94±3.19	0.001	0.066
Week 12	4.25±5.86	2.10±2.59	1.06±3.20	0.002	0.073
Fat free mass change, kg
Week 4	−0.40±4.10	0.63±1.64	0.06±1.45	0.311	0.172
Week 8	0.13±3.09	0.84±1.73	0.19±3.23	0.792	0.479
Week 12	0.70±5.50	1.60±2.78	0.32±2.67	0.138	0.081

Data are presented as mean±SD for full analysis set population. Positive value denotes a reduction and negative value denotes an increase from baseline. p value bolded when significance <0.05.