Weight
weight loss
The mean (SD) body weight at baseline was 38.6 (13.9) kg with a Mean observed body weight versus mean predicted body weight Baseline Observed Mean Body Weight and Height, Predicted Weight and Height, Weight and Height Z-Score, and Weight and Height Percentiles: Treatment Phase Safety PopulationSD, standard deviation.At 90 days, the mean observed weight and predicted weight were 38.5 and 40.2 kg, respectively, with a difference between the means of 1.7 kg. At the end of the study (360 days), the mean observed weight and predicted weight were 41.1 and 42.8 kg, respectively, with the same difference between the means of 1.7 kg as after 3 months of treatment.The mean (SD) weight For subjects who completed the study, smaller decreases or lower-than-expected increases were observed during the second and third months, after which the weight velocity resumed, although at a lower starting weight at 90 days. The average weight decreased from the 68.4 (27.4) percentile to the 64.3 (28.8) percentile during the first month in the treatment phase, with an additional small decrease to the 62.8 (27.7) percentile by 12 months (Approximately the same mean weight percentile was maintained for the remainder of the study. The percentage of subjects with clinically notable weight loss, defined as a weight decrease from baseline >7%, was 8.7% at 30 days. The percentage of subjects with weight loss increased over time, peaking at 14.5% of subjects at 4 months and then declining to 5.2% of subjects at the end of the study (360 days). This time course is consistent with average weight loss observed during the beginning of the treatment phase followed by weight gains later in the study.The mean weight Mean weight The Z-scores for subjects with a baseline BMI <16.1 kg/m