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 protocolEffect of Semaglutide on Regression and Progression of Glycemia in People With Overweight or Obesity but Without Diabetes in the SELECT Trial
Kahn S, Deanfield J, Jeppesen O, Emerson S, Boesgaard T, Colhoun H, Kushner R, Lingvay I, Burguera B, Gajos G, Horn D, Hramiak I, Jastreboff A, Kokkinos A, Maeng M, Matos A, Tinahones F, Lincoff A, Ryan D, Investigators S. Effect of Semaglutide on Regression and Progression of Glycemia in People With Overweight or Obesity but Without Diabetes in the SELECT Trial. Diabetes Care 2024, 47: 1350-1359. PMID: 38907683, PMCID: PMC11282386, DOI: 10.2337/dc24-0491.Peer-Reviewed Original ResearchCardiovascular diseaseMagnitude of weight reductionDouble-blind trialEffect of semaglutideCases of diabetesSubcutaneous semaglutideTreatment armsFollow-upSemaglutideDiabetesHbA1cObesityIntervention exposureGlycemiaPlaceboWeeksBody weightGlycemic outcomesDiseaseWeight reductionNormoglycemiaTrialsParticipantsProgressionKg/m2
2023
Naltrexone/bupropion for binge‐eating disorder: A randomized, double‐blind, placebo‐controlled trial
Grilo C, Lydecker J, Jastreboff A, Pittman B, McKee S. Naltrexone/bupropion for binge‐eating disorder: A randomized, double‐blind, placebo‐controlled trial. Obesity 2023, 31: 2762-2773. PMID: 37751990, PMCID: PMC10600891, DOI: 10.1002/oby.23898.Peer-Reviewed Original ResearchConceptsNaltrexone/bupropionBinge-eating disorderObesity statusLogistic regressionWeight lossPlacebo-controlled trialWeight loss outcomesPrevalent psychiatric disordersEvidence-based treatmentsPost-treatment assessmentBinge-eating frequencyGreater percentage weight lossMedication outcomesRemission ratePharmacological optionsPlaceboBupropionPsychiatric disordersPercentage weight lossMixed modelsDisordersObesityPatientsSignificant reductionWeight reductionTriple–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
2022
Tirzepatide Once Weekly for the Treatment of Obesity
Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal Of Medicine 2022, 387: 205-216. PMID: 35658024, DOI: 10.1056/nejmoa2206038.Peer-Reviewed Original ResearchConceptsBody weightTreatment discontinuationAdverse eventsGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsGlucose-dependent insulinotropic polypeptidePercentage changeDose escalation periodWeight-related complicationsCommon adverse eventsCoprimary end pointsBody mass indexSubstantial global morbidityTreatment of obesityMean percentage changePercentage of participantsMean body weightWeight reductionCardiometabolic measuresTreat populationPlacebo groupWeek 72Mean BMIWeekly dosesDose escalation