2024
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
2023
Triple–Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial
Jastreboff A, Kaplan L, Frías J, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman M. Triple–Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. New England Journal Of Medicine 2023, 389: 514-526. PMID: 37366315, DOI: 10.1056/nejmoa2301972.Peer-Reviewed Original ResearchConceptsBody weightPercentage changePlacebo groupEnd pointGlucagon-like peptide-1Glucose-dependent insulinotropic polypeptideLower starting doseWeight-related conditionsCommon adverse eventsPlacebo-controlled trialPrimary end pointSecondary end pointsBody mass indexTreatment of obesityDose-dependent increaseDose-response relationshipWeight reductionStarting doseAdverse eventsInsulinotropic polypeptideHeart ratePeptide-1Side effectsGlucagon receptorWeeks