Considerations for the design and conduct of pediatric obesity pharmacotherapy clinical trials: Proceedings of expert roundtable meetings

Move away from BMI z-score as a primary outcome; incorporate multiple alternative BMI-related outcomes; measure adiposity/body fat as a prominent secondary end-point

Eligibility criteria should maximize generalizability while maintaining safety

Trial run-in phases are of limited value

Avoid extended follow-up periods after AOM withdrawal, owing to ethical issues (including possible psychological harm) of weight regain without access to other treatments

Value of the randomized, placebo-controlled trial; consider active comparators in addition to, or instead of, placebo to achieve clinical equipoise when appropriate

Protocols should include clear guidance on AOM down-titration to avoid excessive weight reduction when applicable