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
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 reductionTirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial
Garvey W, Frias J, Jastreboff A, le Roux C, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad N, Bunck M, Benabbad I, Zhang X, investigators S, Abalos F, Manghi F, Zaidman C, Vico M, Aizenberg D, Costanzo P, Serra L, MacKinnon I, Hissa M, Vidotti M, Saraiva J, Alves B, Franco D, Moratto O, Murthy S, Goyal G, Yamasaki Y, Sato N, Inoue S, Asakura T, Shestakova M, Khaykina E, Troshina E, Vorokhobina N, Ametov A, Tu S, Yang C, Lee I, Huang C, Ou H, Freeman G, Machineni S, Klein K, Sultan S, Parsa A, Otero-Martinez J, Gonzalez A, Bhargava A, Brian S, Ince C, Plantholt S, Cole J, Lacour A, Vega D, de Souza J, Rohlf J, St. John R, Horowitz B, Audish H, Galindo R, Umpiperrez G, Ard J, Curtis B, Garvey W, Fraser N, Mandry J, Mohseni R, Mayfield R, Powell T, Vance C, Ong S, Lewy-Alterbaum A, Murray A, Al-Karadsheh A, Yacoub T, Roberts K, Fried D, Rosenstock J, Pulla B, Bode B, Frias J, Klaff L, Brazg R, Van J, Tan A, Briskin T, Rhee M, Chaicha-Brom T, Hartley P, Nunez L, Cortes-Maisonet G, Soucie G, Hsia S, Jones T. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet 2023, 402: 613-626. PMID: 37385275, DOI: 10.1016/s0140-6736(23)01200-x.Peer-Reviewed Original ResearchConceptsType 2 diabetesBody mass indexTreatment discontinuationAdverse eventsBodyweight reductionWeight managementGlucagon-like peptide-1 receptor agonistsInteractive web response systemPeptide-1 receptor agonistsGlucose-dependent insulinotropic polypeptideComputer-generated random sequenceFrequent adverse eventsPlacebo-controlled trialSerious adverse eventsIncretin-based therapiesPhase 3 trialWeb response systemTreatment of obesityWeekly tirzepatideCoprimary endpointsRescue therapySafety endpointWeek 72Safety profileStudy treatmentTriple–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