Considerations for the design and conduct of pediatric obesity pharmacotherapy clinical trials: Proceedings of expert roundtable meetings
Kelly A, Bahlke M, Baker J, de Beaufort C, Belin R, Fonseca H, Hale P, Holm J, Hsia D, Jastreboff A, Juliusson P, Murphy M, Pak J, Paul E, Rudolph B, Srivastava G, Tornøe C, Weghuber D, Fox C. Considerations for the design and conduct of pediatric obesity pharmacotherapy clinical trials: Proceedings of expert roundtable meetings. Pediatric Obesity 2024, 19: e13161. PMID: 39289849, DOI: 10.1111/ijpo.13161.Peer-Reviewed Original ResearchAnti-obesity medicationsExcessive weight reductionClinical trialsEnd pointsDown-titrationEligibility criteriaLong-term health outcomesBMI z-scoreActive comparatorEfficacy end pointPlacebo-controlled trialSecondary end pointsRun-in phaseFollow-up periodFollow-up phaseHealth outcomesObesity expertsTrial eligibility criteriaClinical careWeight reductionMultidisciplinary groupClinical trial protocolsPrimary outcomeWeight regainTrial protocol