Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects
Table 4
Mean changes (reduction) in primary and secondary parameters from baseline to week 12.
Parameters
FAS population
IQP-AE-103 LD ()
IQP-AE-103 HD ()
Placebo ()
Mean ± s.d.
values, vs. placebo
Mean ± s.d.
values, vs. placebo
Mean ± s.d.
Body weight (kg)
3.01 ± 2.19
<0.001
5.03 ± 2.50
<0.001
0.98 ± 2.06
BMI (kg/m2)
1.09 ± 0.75
<0.001
1.75 ± 0.83
<0.001
0.34 ± 0.77
Waist circumference (cm)
2.5 ± 2.4
0.001
4.1 ± 3.3
<0.001
0.9 ± 1.6
Hip circumference (cm)
2.8 ± 2.5
0.001
4.0 ± 3.0
<0.001
0.9 ± 1.2
Body fat mass (kg)
2.62 ± 3.83
0.005
3.15 ± 2.41
<0.001
0.23 ± 2.74
Fat-free mass (kg)
0.39 ± 3.68
0.931
1.80 ± 2.38
0.124
0.75 ± 2.93
FAS = full analysis set; LD = low dose; HD = high dose.
