Table 3. Suggestions regarding endpoint selection.

Primary efficacy endpoint: percent change in BMI from baseline Additional endpoints to report: absolute change in BMI, change in BMI z-score, and the proportion with ≥5% and ≥10% BMI reduction from baseline Secondary endpoints: include measures in the physiological (cardiometabolic risk factors) and quality of life domains; measures of psychological functioning, eating behaviors, and/or diet should also be considered Safety endpoints: include serial assessment of Tanner stage and height; measures of neuropsychiatric function should also be considered; additional safety endpoints may be necessary based on the mechanism(s) of action of the drug(s) under investigation