{"ctNumber":"2025-522312-16-00","ctStatus":"Authorised","startDateEU":"2026-02-27","decisionDate":"2026-01-29T13:07:25.72","publishDate":"2026-09-11T03:33:07.427202835","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":137719,"rowSubjectCount":798,"rowCountriesInfo":[{"eutctId":100000000432,"name":"Japan","isoNumber":392,"isoAlpha2Code":"JP","isoAlpha3Code":"JPN","current":true},{"eutctId":100000000557,"name":"United States","isoNumber":840,"isoAlpha2Code":"US","isoAlpha3Code":"USA","current":true},{"eutctId":100000000325,"name":"Argentina","isoNumber":32,"isoAlpha2Code":"AR","isoAlpha3Code":"ARG","current":true},{"eutctId":100000000362,"name":"China","isoNumber":156,"isoAlpha2Code":"CN","isoAlpha3Code":"CHN","current":true},{"eutctId":100000000538,"name":"Taiwan","isoNumber":158,"isoAlpha2Code":"TW","isoAlpha3Code":"TWN","current":true},{"eutctId":100000000438,"name":"Korea, Democratic People's Republic of","isoNumber":408,"isoAlpha2Code":"KP","isoAlpha3Code":"PRK","current":true}],"products":[{"id":573425,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713219","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713219","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713219","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713219","sponsorProductCodeEdit":"LY3537031","devices":[{"id":22629,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":573424,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713221","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713221","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713221","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"chemical","evCode":"PRD12713221","sponsorProductCodeEdit":"LY3537031","devices":[{"id":22628,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":573423,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPharmForm":"N/A","euMpNumber":"N/A","marketingAuthNumber":"N/A","prodName":"Placebo to match LY","pharmForm":"N/A","activeSubstanceName":"N/A","euSubstNumber":"N/A","productOtherName":"N/A","authorisationCountryCode":"IS","nameOrg":"N/A","sponsorSubstanceCode":"N/A","atcCode":"N/A","atcName":"N/A","atcTermLevel":"N/A","activeSubstanceOtherDescriptiveName":"N/A"},"isPaediatricFormulation":false,"mpRoleInTrial":"3","timeUnitCode":"2","evCode":"N/A","devices":[],"characteristics":[],"routes":[],"allSubstancesChemicals":false,"productName":"Placebo to match LY","jsonActiveSubstanceNames":"n/a","pharmaceuticalFormDisplay":"N/A"},{"id":573426,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713220","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713220","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713220","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"chemical","evCode":"PRD12713220","sponsorProductCodeEdit":"LY3537031","devices":[{"id":22630,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"J2S-MC-GZMP: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)","fullTitleTranslations":[],"publicTitle":"A Study of Brenipatide in Participants With Alcohol Use Disorder (RENEW-ALC-2)","publicTitleTranslations":[],"shortTitle":"J2S-MC-GZMP","secondaryIdentifyingNumbers":{"whoUniversalTrialNumber":{"id":562071,"number":"U1111-1321-8938"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"In line with the EMA Appendix on disclosure rules to the “Functional specifications for the EU portal and EU database to be audited- EMA/42176/2014”, the trial meets the definition of category 2 trial since it is a Phase III trial assessing a non-authorised investigational medicinal product  to investigate safety and efficacy and potential dosage regimes.","trialCategoryId":127184},"medicalCondition":{"partIMedicalConditions":[{"id":144136,"medicalCondition":"Alcohol Use Disorder","medicalConditionTranslations":[],"isConditionRareDisease":false}]},"trialObjective":{"trialScopes":[{"code":"6","trialScopeId":418470},{"code":"4","trialScopeId":418475},{"code":"1","trialScopeId":418471},{"code":"9","trialScopeId":418472},{"code":"5","trialScopeId":418473},{"code":"3","trialScopeId":418474}],"mainObjective":"Period 1 \nPrimary Objective \nTo demonstrate that at least 1 dose level of brenipatide is superior to placebo for the primary endpoint\nPeriod 2\nPrimary Objective\nFor brenipatide responders from Period 1: To evaluate the ability of brenipatide \n(pooled across doses) to maintain a general reduction in alcohol consumption \nendpoint","mainObjectiveTranslations":[],"secondaryObjectives":[]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":938380,"number":1,"principalInclusionCriteria":"Are seeking treatment and are motivated to stop or cut down on drinking.","principalInclusionCriteriaTranslations":[]},{"id":938381,"number":2,"principalInclusionCriteria":"Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as   •  self-inject study intervention Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the study intervention.   •  store and use the provided blinded study intervention, as directed   •  maintain electronic and paper study diaries, as applicable, and   •  complete the required questionnaires.","principalInclusionCriteriaTranslations":[]}],"principalExclusionCriteria":[{"id":1603399,"number":1,"principalExclusionCriteria":"Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.","principalExclusionCriteriaTranslations":[]},{"id":1603400,"number":2,"principalExclusionCriteria":"Have answered “yes” to either Question 4 or Question 5 on the “Suicidal Ideation” portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered “yes” to any of the suicide-related behaviors on the “Suicidal Behavior” portion of the C-SSRS and the behavior occurred within the past 6 months","principalExclusionCriteriaTranslations":[]},{"id":1603401,"number":3,"principalExclusionCriteria":"Have either of the following:   •  history of advanced liver disease, including advanced liver fibrosis [Stage 3] or cirrhosis [Stage 4], based on prior biomarkers, imaging or liver biopsy, OR   •  history of acute alcohol-associated hepatitis based onprior liver biopsy.","principalExclusionCriteriaTranslations":[]},{"id":1603402,"number":4,"principalExclusionCriteria":"Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).","principalExclusionCriteriaTranslations":[]}]},"endPoint":{"primaryEndPoints":[{"id":1094332,"number":1,"endPoint":"Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)","isPrimary":true,"endPointTranslations":[]}],"secondaryEndPoints":[]},"trialDuration":{"estimatedGlobalEndDate":"2028-04-01","estimatedEndDate":"2028-04-01","estimatedRecruitmentStartDate":"2026-01-15"},"sourceOfMonetarySupport":[],"populationOfTrialSubjects":{"ageRanges":[{"id":378436,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{"planToShareIPD":"1"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[{"id":59704,"competentAuthority":{"id":848930,"organisation":{"id":890594,"type":"EU Institution/Body/Agency","typeCode":"14","name":"European Medicines Agency","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100013412","organisationLocationStatus":"Active"},"address":{"addressId":944310,"oneLine":"P. O. Box 71010","addressLine1":"P. O. Box 71010","addressLine2":"","addressLine3":"","addressLine4":"","city":"Amsterdam","postcode":"1008 BA","country":2029,"countryName":"Netherlands"},"isBusinessKeyValidated":true,"businessKey":"ORG-100013412"}}],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-09-09","conclusionDate":"2026-09-09","therapeuticAreas":[{"code":"34","name":"Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]"}],"medicalConditions":[{"id":144136,"medicalCondition":"Alcohol Use Disorder","isConditionRareDisease":false}],"sponsors":[{"id":156754,"primary":true,"publicContacts":[{"id":462697,"type":"Public","functionalName":"Lilly Clinical Trials information desk","functionalEmailAddress":"EU_lilly_clinical_trials@lilly.com","telephone":"00353214232400","organisation":{"id":794953,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":462698,"type":"Scientific","functionalName":"Lilly Clinical Trials information desk","functionalEmailAddress":"EU_lilly_clinical_trials@lilly.com","telephone":"00353214232400","organisation":{"id":794953,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"}}],"thirdParties":[{"id":714171,"organisationAddress":{"id":831670,"organisation":{"id":871179,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Cleveland Clinic Foundation","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028017","organisationLocationStatus":"Active"},"address":{"addressId":923569,"oneLine":"9500 Euclid Avenue","addressLine1":"9500 Euclid Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Cleveland","postcode":"44195-0001","country":840,"countryName":"United States"},"phone":"2164456439","email":"brennat@ccf.org","isBusinessKeyValidated":true,"businessKey":"ORG-100028017"},"sponsorDuties":[{"id":1107851,"code":"6"}],"phoneNumber":"2164456439","email":"brennat@ccf.org"},{"id":714172,"organisationAddress":{"id":831650,"organisation":{"id":871159,"type":"Non-Pharmaceutical company","typeCode":"11","name":"The Hibbert Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100047639","organisationLocationStatus":"Active"},"address":{"addressId":923546,"oneLine":"400 Pennington Avenue","addressLine1":"400 Pennington Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Trenton","postcode":"08618-3105","country":840,"countryName":"United States"},"phone":"6092226000","email":"poynter_leah@network.lilly.com","isBusinessKeyValidated":true,"businessKey":"ORG-100047639"},"sponsorDuties":[{"id":1107852,"code":"15","value":"Patient Screening, Recruitment, and/or Retention"}],"phoneNumber":"6092226000","email":"poynter_leah@network.lilly.com"},{"id":714166,"organisationAddress":{"id":831662,"organisation":{"id":871171,"type":"Pharmaceutical company","typeCode":"10","name":"RWS Life Sciences Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042348","organisationLocationStatus":"Active"},"address":{"addressId":923560,"oneLine":"101 East River Drive","addressLine1":"101 East River Drive","addressLine2":"","addressLine3":"","addressLine4":"","city":"East Hartford","postcode":"06108-3285","country":840,"countryName":"United States"},"phone":"18607276000","email":"Lucy.Browning@rws.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042348"},"sponsorDuties":[{"id":1107844,"code":"15","value":"Copyright licensing, Linguistically Validated Translations"},{"id":1107845,"code":"6"}],"phoneNumber":"18607276000","email":"Lucy.Browning@rws.com"},{"id":714173,"organisationAddress":{"id":831654,"organisation":{"id":871163,"type":"Pharmaceutical company","typeCode":"10","name":"Labcorp Central Laboratory Services LP","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100032236","organisationLocationStatus":"Active"},"address":{"addressId":923551,"oneLine":"8211 Scicor Drive","addressLine1":"8211 Scicor Drive","addressLine2":"","addressLine3":"","addressLine4":"","city":"Indianapolis","postcode":"46214-2942","country":840,"countryName":"United States"},"phone":"317711200","email":"alexander.torline@labcorp.com","isBusinessKeyValidated":true,"businessKey":"ORG-100032236"},"sponsorDuties":[{"id":1107853,"code":"15","value":"Laboratory & Diagnostics"},{"id":1107854,"code":"4"}],"phoneNumber":"317711200","email":"alexander.torline@labcorp.com"},{"id":714170,"organisationAddress":{"id":831672,"organisation":{"id":871181,"type":"Non-Pharmaceutical company","typeCode":"11","name":"Greenphire LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100041621","organisationLocationStatus":"Active"},"address":{"addressId":923571,"oneLine":"1018 West 9th Avenue Suite 200","addressLine1":"1018 West 9th Avenue Suite 200","addressLine2":"","addressLine3":"","addressLine4":"","city":"King Of Prussia","postcode":"19406-1225","country":840,"countryName":"United States"},"phone":"14842848009","email":"kathleen.schubach@greenphire.com","isBusinessKeyValidated":true,"businessKey":"ORG-100041621"},"sponsorDuties":[{"id":1107850,"code":"15","value":"Patient Screening, Recruitment and Retention"}],"phoneNumber":"14842848009","email":"kathleen.schubach@greenphire.com"},{"id":714167,"organisationAddress":{"id":831677,"organisation":{"id":871186,"type":"Pharmaceutical company","typeCode":"10","name":"Trialbee AB","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100051369","organisationLocationStatus":"Active"},"address":{"addressId":923576,"oneLine":"Sodra Tullgatan 3, Malmo S T Petri","addressLine1":"Sodra Tullgatan 3","addressLine2":"Malmo S T Petri","addressLine3":"","addressLine4":"","city":"Malmo","postcode":"211 40","country":2028,"countryName":"Sweden"},"phone":"2679665311","email":"bill.abbott@trialbee.com","isBusinessKeyValidated":true,"businessKey":"ORG-100051369"},"sponsorDuties":[{"id":1107846,"code":"15","value":"Patient Referral, Recruitment, Screening, and/or Retention"}],"phoneNumber":"2679665311","email":"bill.abbott@trialbee.com"},{"id":714168,"organisationAddress":{"id":831645,"organisation":{"id":871154,"type":"Pharmaceutical company","typeCode":"10","name":"Iqvia Biotech LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100008704","organisationLocationStatus":"Active"},"address":{"addressId":923540,"oneLine":"2400 Ellis Road Level 4","addressLine1":"2400 Ellis Road Level 4","addressLine2":"","addressLine3":"","addressLine4":"","city":"Durham","postcode":"27703-5543","country":840,"countryName":"United States"},"phone":"5215541887535","email":"nadiezda.lozano@iqvia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100008704"},"sponsorDuties":[{"id":1107847,"code":"1"}],"phoneNumber":"5215541887535","email":"nadiezda.lozano@iqvia.com"},{"id":714174,"organisationAddress":{"id":831693,"organisation":{"id":871202,"type":"Pharmaceutical company","typeCode":"10","name":"Bioagilytix Labs LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100013030","organisationLocationStatus":"Active"},"address":{"addressId":923594,"oneLine":"2300 Englert Drive Suite G","addressLine1":"2300 Englert Drive Suite G","addressLine2":"","addressLine3":"","addressLine4":"","city":"Durham","postcode":"27713-4450","country":840,"countryName":"United States"},"phone":"9192871555","email":"Jennifer.zemo@bioagilytix.com","isBusinessKeyValidated":true,"businessKey":"ORG-100013030"},"sponsorDuties":[{"id":1107855,"code":"15","value":"Immunogenicity"}],"phoneNumber":"9192871555","email":"Jennifer.zemo@bioagilytix.com"},{"id":714175,"organisationAddress":{"id":832555,"organisation":{"id":872458,"type":"Health care","typeCode":"2","name":"CRIO Inc","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000015877","organisationLocationStatus":"Active"},"address":{"addressId":924678,"oneLine":"68 Harrison Ave #605","addressLine1":"68 Harrison Ave #605","addressLine2":"","addressLine3":"","addressLine4":"","city":"Boston","postcode":"MA 02111","country":840,"countryName":"United States"},"phone":"+16173029845","email":"riya.n@clinicalresearch.io","isBusinessKeyValidated":false,"businessKey":"ORL-000015877"},"sponsorDuties":[{"id":1107856,"code":"15","value":"eSource, eCOA"}],"phoneNumber":"+16173029845","email":"riya.n@clinicalresearch.io"},{"id":714169,"organisationAddress":{"id":831691,"organisation":{"id":871200,"type":"Educational Institution","typeCode":"1","name":"Indiana University","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100047213","organisationLocationStatus":"Active"},"address":{"addressId":923592,"oneLine":"107 South Indiana Avenue","addressLine1":"107 South Indiana Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Bloomington","postcode":"47405-7000","country":840,"countryName":"United States"},"phone":"3172748157","email":"huanxi@iu.edu","isBusinessKeyValidated":true,"businessKey":"ORG-100047213"},"sponsorDuties":[{"id":1107848,"code":"10"},{"id":1107849,"code":"15","value":"Statistics, Data, and Analytics (SDNA)"}],"phoneNumber":"3172748157","email":"huanxi@iu.edu"}],"organisation":{"id":794953,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"},"addresses":[{"id":756301,"organisation":{"id":794953,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"},"address":{"addressId":833105,"oneLine":"1 Lilly Corporate Center","addressLine1":"1 Lilly Corporate Center","addressLine2":"","addressLine3":"","addressLine4":"","city":"Indianapolis","postcode":"46285-0001","country":840,"countryName":"United States"},"isBusinessKeyValidated":true,"businessKey":"ORG-100000156"}],"isCommercial":true,"commercial":"Commercial"}],"trialCategoryCode":"2","trialCategoryJustificationComment":"In line with the EMA Appendix on disclosure rules to the “Functional specifications for the EU portal and EU database to be audited- EMA/42176/2014”, the trial meets the definition of category 2 trial since it is a Phase III trial assessing a non-authorised investigational medicinal product  to investigate safety and efficacy and potential dosage regimes.","partOneTherapeuticAreas":[{"id":1209496,"therapeuticArea":{"code":"34","name":"Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]"}}],"productRoleGroupInfos":[{"id":426572,"comments":"Brenipatide, Brenipatide, Brenipatide","productRoleCode":"1","productRoleName":"Test","products":[{"id":573424,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713221","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713221","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713221","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"chemical","evCode":"PRD12713221","sponsorProductCodeEdit":"LY3537031","devices":[{"id":22628,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":573425,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713219","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713219","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713219","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713219","sponsorProductCodeEdit":"LY3537031","devices":[{"id":22629,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":573426,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713220","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713220","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713220","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"chemical","evCode":"PRD12713220","sponsorProductCodeEdit":"LY3537031","devices":[{"id":22630,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"}]},{"id":426571,"comments":"Placebo to match LY","productRoleCode":"3","productRoleName":"Placebo","products":[{"id":573423,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPharmForm":"N/A","euMpNumber":"N/A","marketingAuthNumber":"N/A","prodName":"Placebo to match LY","pharmForm":"N/A","activeSubstanceName":"N/A","euSubstNumber":"N/A","productOtherName":"N/A","authorisationCountryCode":"IS","nameOrg":"N/A","sponsorSubstanceCode":"N/A","atcCode":"N/A","atcName":"N/A","atcTermLevel":"N/A","activeSubstanceOtherDescriptiveName":"N/A"},"isPaediatricFormulation":false,"mpRoleInTrial":"3","timeUnitCode":"2","evCode":"N/A","devices":[],"characteristics":[],"routes":[],"allSubstancesChemicals":false,"productName":"Placebo to match LY","jsonActiveSubstanceNames":"n/a","pharmaceuticalFormDisplay":"N/A"}]}],"isLowIntervention":false},"authorizedPartsII":[{"id":318003,"mscId":50625,"mscInfo":{"id":50625,"clinicalTrialId":23912,"countryOrganisationId":2002,"reportingStatusCode":"Authorised","fromDate":"2026-02-02","toDate":"2026-02-02","isProposedRms":false,"expressDecision":"unwilling","countryName":"Belgium","organisationInfo":{},"firstDecisionDate":"2026-02-06","trialStatus":"Authorised","trialPeriod":[{"id":76373,"trialStartDate":"2026-03-03","fromDate":"2026-03-06"},{"id":76374,"trialStartDate":"2026-03-03","fromDate":"2026-03-06"}],"trialRecruitmentPeriod":[{"id":105371,"recruitmentStartDate":"2026-03-10","fromDate":"2026-03-27"},{"id":105372,"recruitmentStartDate":"2026-03-10","fromDate":"2026-03-27"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":122205,"trialStartDate":"2026-03-03","fromDate":"2026-03-06"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2026-03-10"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":264678,"mscId":50625,"trialStatus":"Authorised","trialStatusDate":"2026-02-06T10:44:30.013"},{"id":109380,"mscId":50625,"trialStatus":"Under evaluation","trialStatusDate":"2025-10-22T20:26:17.839"}],"applicationTypeMsc":"1","mscName":"Belgium","assessmentOutcome":"acceptable_conditions","assessmentOutcomeDate":"2026-07-10","decision":"authorized","decisionDate":"2026-02-06"},"decisionDate":"2026-02-06","recruitmentSubjectCount":84,"trialSites":[{"id":2224356,"organisationAddressInfo":{"id":849230,"organisation":{"id":890954,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Kormont","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100046894","organisationLocationStatus":"Active"},"address":{"addressId":944651,"oneLine":"Kwaremontplein 45","addressLine1":"Kwaremontplein 45","addressLine2":"","addressLine3":"","addressLine4":"","city":"Kluisbergen","postcode":"9690","country":2002,"countryName":"Belgium"},"phone":"+32496376259","email":"klaas.vercruysse@telenet.be","isBusinessKeyValidated":true,"businessKey":"ORG-100046894"},"personInfo":{"id":2467032,"firstName":"Klaas","lastName":"Vercruysse","telephone":"+32496376259","email":"klaas.vercruysse@telenet.be","title":"1"},"departmentName":"Kormont"},{"id":2224357,"organisationAddressInfo":{"id":849231,"organisation":{"id":890955,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Anima","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100047480","organisationLocationStatus":"Active"},"address":{"addressId":944652,"oneLine":"Alkerstraat 28","addressLine1":"Alkerstraat 28","addressLine2":"","addressLine3":"","addressLine4":"","city":"Alken","postcode":"3570","country":2002,"countryName":"Belgium"},"phone":"0032473861079","email":"erik.buntinx@anima-alken.be","isBusinessKeyValidated":true,"businessKey":"ORG-100047480"},"personInfo":{"id":2467033,"firstName":"Erik","lastName":"Buntinx","telephone":"0032473861079","email":"erik.buntinx@anima-alken.be","title":"1"},"departmentName":"Amina"},{"id":2224355,"organisationAddressInfo":{"id":849234,"organisation":{"id":890958,"type":"Pharmaceutical company","typeCode":"10","name":"Meclinas","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100050302","organisationLocationStatus":"Active"},"address":{"addressId":944655,"oneLine":"Stationsstraat 102-108","addressLine1":"Stationsstraat 102-108","addressLine2":"","addressLine3":"","addressLine4":"","city":"Mechelen","postcode":"2800","country":2002,"countryName":"Belgium"},"phone":"003215792797","email":"claudia.cornelis@meclinas.com","isBusinessKeyValidated":true,"businessKey":"ORG-100050302"},"personInfo":{"id":2467031,"firstName":"Claudia","lastName":"Cornelis","telephone":"003215792797","email":"claudia.cornelis@meclinas.com","title":"1"},"departmentName":"Meclinas"}],"applicationStatusCode":"Authorised"},{"id":324384,"mscId":50626,"mscInfo":{"id":50626,"clinicalTrialId":23912,"countryOrganisationId":2013,"reportingStatusCode":"Authorised","fromDate":"2025-12-04","toDate":"2025-12-04","isProposedRms":true,"expressDecision":"willing","countryName":"Germany","organisationInfo":{},"firstDecisionDate":"2026-01-29","trialStatus":"Authorised","trialPeriod":[{"id":76189,"trialStartDate":"2026-02-27","fromDate":"2026-03-04"},{"id":76190,"trialStartDate":"2026-02-27","fromDate":"2026-03-04"}],"trialRecruitmentPeriod":[{"id":102692,"recruitmentStartDate":"2026-03-03","fromDate":"2026-03-04"},{"id":102693,"recruitmentStartDate":"2026-03-03","fromDate":"2026-03-04"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":121864,"trialStartDate":"2026-02-27","fromDate":"2026-03-04"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2026-03-03"},"isWillingAtDayThreeView":true,"clinicalTrialStatusHistory":[{"id":263291,"mscId":50626,"trialStatus":"Authorised","trialStatusDate":"2026-01-29T13:07:25.013"},{"id":109381,"mscId":50626,"trialStatus":"Under evaluation","trialStatusDate":"2025-10-22T20:26:17.87"}],"applicationTypeMsc":"1","mscName":"Germany","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-08-28","decision":"authorized","decisionDate":"2026-01-29"},"decisionDate":"2026-01-29","recruitmentSubjectCount":67,"trialSites":[{"id":2274085,"organisationAddressInfo":{"id":830355,"organisation":{"id":869824,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"FutureMeds GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100039142","organisationLocationStatus":"Active"},"address":{"addressId":921965,"oneLine":"Platz Der Deutschen Einheit 4","addressLine1":"Platz Der Deutschen Einheit 4","addressLine2":"","addressLine3":"","addressLine4":"","city":"Offenbach Am Main","postcode":"63065","country":2013,"countryName":"Germany"},"phone":"4969247433840","email":"info@futuremeds.com","isBusinessKeyValidated":true,"businessKey":"ORG-100039142"},"personInfo":{"id":2521526,"firstName":"Florieke","lastName":"Berfelo","telephone":"4969247433840","email":"info@futuremeds.com","title":"1"},"departmentName":"N/A"},{"id":2274086,"organisationAddressInfo":{"id":830343,"organisation":{"id":869812,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Zentralinstitut Fuer Seelische Gesundheit","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100013535","organisationLocationStatus":"Active"},"address":{"addressId":921951,"oneLine":"Luisenring J 5","addressLine1":"Luisenring J 5","addressLine2":"","addressLine3":"","addressLine4":"","city":"Mannheim","postcode":"68159","country":2013,"countryName":"Germany"},"phone":"4962117033888","email":"patrick.bach@zi-mannheim.de","isBusinessKeyValidated":true,"businessKey":"ORG-100013535"},"personInfo":{"id":2521527,"firstName":"Patrick","lastName":"Bach","telephone":"4962117033888","email":"patrick.bach@zi-mannheim.de","title":"2"},"departmentName":"N/A"},{"id":2274088,"organisationAddressInfo":{"id":830352,"organisation":{"id":869821,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"FutureMeds GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100039142","organisationLocationStatus":"Active"},"address":{"addressId":921962,"oneLine":"Wilmersdorfer Strasse 79, Charlottenburg","addressLine1":"Wilmersdorfer Strasse 79","addressLine2":"Charlottenburg","addressLine3":"","addressLine4":"","city":"Berlin","postcode":"10629","country":2013,"countryName":"Germany"},"phone":"49304397410","email":"peter.hahn@futuremeds.com","isBusinessKeyValidated":true,"businessKey":"ORG-100039142"},"personInfo":{"id":2521529,"firstName":"Peter","lastName":"Hahn","telephone":"49304397410","email":"peter.hahn@futuremeds.com","title":"1"},"departmentName":"N/A"},{"id":2274090,"organisationAddressInfo":{"id":830344,"organisation":{"id":869813,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Klinische Forschung Schwerin GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100040436","organisationLocationStatus":"Active"},"address":{"addressId":921952,"oneLine":"Friedrichstrasse 1, Altstadt","addressLine1":"Friedrichstrasse 1","addressLine2":"Altstadt","addressLine3":"","addressLine4":"","city":"Schwerin","postcode":"19055","country":2013,"countryName":"Germany"},"phone":"49385557740","email":"christine.paschen@pratia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100040436"},"personInfo":{"id":2521531,"firstName":"Christine","lastName":"Paschen","telephone":"49385557740","email":"christine.paschen@pratia.com","title":"1"},"departmentName":"N/A"},{"id":2274084,"organisationAddressInfo":{"id":830349,"organisation":{"id":869818,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Klinische Forschung Hamburg GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042069","organisationLocationStatus":"Active"},"address":{"addressId":921959,"oneLine":"Hoheluftchaussee 18, Hoheluft-Ost","addressLine1":"Hoheluftchaussee 18","addressLine2":"Hoheluft-Ost","addressLine3":"","addressLine4":"","city":"Hamburg","postcode":"20253","country":2013,"countryName":"Germany"},"phone":"0404607630","email":"christian.deckert@pratia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042069"},"personInfo":{"id":2521525,"firstName":"Christian","lastName":"Deckert","telephone":"0404607630","email":"christian.deckert@pratia.com","title":"1"},"departmentName":"N/A"},{"id":2274089,"organisationAddressInfo":{"id":830656,"organisation":{"id":870161,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Velocity Clinical Research Germany GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042412","organisationLocationStatus":"Active"},"address":{"addressId":922317,"oneLine":"Ansbacher Strasse 17-19, Schoeneberg","addressLine1":"Ansbacher Strasse 17-19","addressLine2":"Schoeneberg","addressLine3":"","addressLine4":"","city":"Berlin","postcode":"10787","country":2013,"countryName":"Germany"},"phone":"493020859400","email":"schenkenberger@klinische-forschung-berlin.de","isBusinessKeyValidated":true,"businessKey":"ORG-100042412"},"personInfo":{"id":2521530,"firstName":"Isabelle","lastName":"Schenkenberger","telephone":"493020859400","email":"schenkenberger@klinische-forschung-berlin.de","title":"1"},"departmentName":"N/A"},{"id":2274087,"organisationAddressInfo":{"id":830353,"organisation":{"id":869822,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Klinische Forschung Dresden GmbH","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100040974","organisationLocationStatus":"Active"},"address":{"addressId":921963,"oneLine":"Prager Strasse 10, Seevorstadt-Ost/Grosser Garten","addressLine1":"Prager Strasse 10","addressLine2":"Seevorstadt-Ost/Grosser Garten","addressLine3":"","addressLine4":"","city":"Dresden","postcode":"01069","country":2013,"countryName":"Germany"},"phone":"00493512052780","email":"heymer@kfgn.de","isBusinessKeyValidated":true,"businessKey":"ORG-100040974"},"personInfo":{"id":2521528,"firstName":"Peter","lastName":"Heymer","telephone":"00493512052780","email":"heymer@kfgn.de","title":"1"},"departmentName":"N/A"}],"applicationStatusCode":"Authorised"}],"applicationInfo":[{"id":55141,"type":"INITIAL","status":"Authorised","ctNumber":"2025-522312-16-00","trialStatus":"Authorised","submissionDate":"2025-10-22","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-29"},"partIIInfo":[{"id":271421,"mscId":50625,"mscInfo":{"id":50625,"mscName":"Belgium","countryOrganisationId":2002,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-02-04","decision":"authorized","decisionDate":"2026-02-06","reportingStatusCode":"Authorised","countryName":"Belgium","trialStatus":"Authorised","firstDecisionDate":"2026-02-06"},"applicationStatusCode":"Authorised"},{"id":263858,"mscId":50626,"mscInfo":{"id":50626,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-12","decision":"authorized","decisionDate":"2026-01-29","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2026-01-29"},"applicationStatusCode":"Authorised"}],"decisionDate":"2026-01-29","ctMSCsByApplication":[{"id":50625,"mscName":"Belgium","reportingStatusCode":"Authorised"},{"id":50626,"mscName":"Germany","reportingStatusCode":"Authorised"}],"businessKey":"IN","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":107180,"applicationId":55141,"mscId":50626,"mscName":"Germany","decisionDate":"2026-01-29T13:07:25.72","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":263858,"part1Id":114340,"applicationType":"INITIAL","isRMS":true},{"id":108450,"applicationId":55141,"mscId":50625,"mscName":"Belgium","decisionDate":"2026-02-06T10:44:30.595","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":271421,"part1Id":114340,"applicationType":"INITIAL","isRMS":false}]},{"id":81476,"type":"SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2025-522312-16-00","trialStatus":"Authorised","submissionDate":"2026-04-24","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-06-17"},"partIIInfo":[{"id":304212,"mscId":50626,"mscInfo":{"id":50626,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-05-11","decision":"authorized","decisionDate":"2026-01-29","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2026-01-29"},"applicationStatusCode":"Authorised"},{"id":318003,"mscId":50625,"mscInfo":{"id":50625,"mscName":"Belgium","countryOrganisationId":2002,"assessmentOutcome":"acceptable_conditions","assessmentOutcomeDate":"2026-07-10","decision":"authorized","decisionDate":"2026-02-06","reportingStatusCode":"Authorised","countryName":"Belgium","trialStatus":"Authorised","firstDecisionDate":"2026-02-06"},"applicationStatusCode":"Authorised"}],"decisionDate":"2026-06-17","ctMSCsByApplication":[{"id":50626,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":50625,"mscName":"Belgium","reportingStatusCode":"Authorised"}],"businessKey":"SM-3","modScope":"PART_I_AND_PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":129054,"applicationId":81476,"mscId":50626,"mscName":"Germany","decisionDate":"2026-06-17T15:47:07.854","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":304212,"part1Id":128824,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":true},{"id":132463,"applicationId":81476,"mscId":50625,"mscName":"Belgium","decisionDate":"2026-07-10T16:38:51.064","decision":"authorized_conditions","assessmentOutcome":"acceptable_conditions","eventType":"decision","part2Id":318003,"part1Id":128824,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false}]},{"id":90139,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2025-522312-16-00","trialStatus":"Authorised","submissionDate":"2026-07-20","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-06-17"},"partIIInfo":[],"decisionDate":"2026-07-20","ctMSCsByApplication":[{"id":50626,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":50625,"mscName":"Belgium","reportingStatusCode":"Authorised"}],"businessKey":"NSM-1","modScope":"PART_I","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":133717,"applicationId":90139,"mscId":50626,"mscName":"Germany","decisionDate":"2026-07-20T15:50:12.957","decision":"authorized","eventType":"decision","part1Id":137519,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":true},{"id":133717,"applicationId":90139,"mscId":50625,"mscName":"Belgium","decisionDate":"2026-07-20T15:50:12.957","decision":"authorized","eventType":"decision","part1Id":137519,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}]},{"id":90255,"type":"SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2025-522312-16-00","trialStatus":"Authorised","submissionDate":"2026-08-03","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-09-09"},"partIIInfo":[{"id":324384,"mscId":50626,"mscInfo":{"id":50626,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-08-28","decision":"authorized","decisionDate":"2026-01-29","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2026-01-29"},"applicationStatusCode":"Authorised"},{"id":324383,"mscId":50625,"mscInfo":{"id":50625,"mscName":"Belgium","countryOrganisationId":2002,"decision":"authorized","decisionDate":"2026-02-06","reportingStatusCode":"Authorised","countryName":"Belgium","trialStatus":"Authorised","firstDecisionDate":"2026-02-06"},"applicationStatusCode":"Authorised"}],"decisionDate":"2026-09-10","ctMSCsByApplication":[{"id":50626,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":50625,"mscName":"Belgium","reportingStatusCode":"Authorised"}],"businessKey":"SM-5","modScope":"PART_I_AND_PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":141348,"applicationId":90255,"mscId":50626,"mscName":"Germany","decisionDate":"2026-09-10T08:53:31.198","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":324384,"part1Id":137719,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":true}]}],"trialGlobalEnd":[],"memberStatesConcerned":[{"mscName":"Germany","mscId":50626,"firstDecisionDate":"2026-01-29T13:07:25.72","lastDecisionDate":"2026-09-10T08:53:31.198","mscPublicStatusCode":4},{"mscName":"Belgium","mscId":50625,"firstDecisionDate":"2026-02-06T10:44:30.595","lastDecisionDate":"2026-07-10T16:38:51.064","mscPublicStatusCode":4}],"eudraCt":{"isTransitioned":false}},"events":{"temporaryHaltList":[],"trialEvents":[{"mscId":50625,"mscName":"Belgium","events":[{"notificationType":"START_OF_TRIAL","date":"2026-03-03"},{"notificationType":"START_OF_RECRUITMENT","date":"2026-03-10"}]},{"mscId":50626,"mscName":"Germany","events":[{"notificationType":"START_OF_TRIAL","date":"2026-02-27"},{"notificationType":"START_OF_RECRUITMENT","date":"2026-03-03"}]}],"unexpectedEvents":[],"seriousBreaches":[],"urgentSafetyMeasures":[]},"results":{},"documents":[{"title":"L2_Other Subject Information_IRB Notification Letter_IQVIA 8.0.1","uuid":"4edecdc2-63c0-42f5-b9a2-df3fb9807825","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1","systemVersion":"1"},{"title":"K1_Recruitment Arrangements_Recruitment and Informed consent procedure_BE","uuid":"3e9fc3c7-935a-44e9-9ce4-4112dbb52d70","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment Material_Meclinas Slogans_Redacted","uuid":"20b38431-0a18-4a07-916a-baea79eb08b5","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"3.0","systemVersion":"2"},{"title":"K2_Recruitment Material_Meclinas Images_Redacted","uuid":"9191de9e-8f16-4e7c-9df1-af9662750bec","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K1_Recruitment Arrangements_Meclinas Recruitment Plan_Redacted","uuid":"e4ca47e3-6834-4362-8a5a-6a57bcc4c32b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":37,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"3.0","systemVersion":"2"},{"title":"K2_Recruitment material_Letter Doctor Referral_BEFR_Redacted","uuid":"c8ec488d-31fb-4e88-bc52-86c3cb760155","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"2"},{"title":"K2_Recruitment material_Letter Doctor Referral_BEDU_Redacted","uuid":"c21a0844-4fa9-4caf-9ea7-ad92ec1342cd","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"2"},{"title":"K2_Recruitment material_Brochure_BEDU_Redacted","uuid":"16e60984-9433-41a7-b4bd-e4b691e1d194","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"2"},{"title":"K2_Recruitment material_Brochure_BEFR_Redacted","uuid":"3b467ce3-dab8-4a4e-b889-ff81033385d6","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment Material_Meclinas Website text_Redacted","uuid":"0e0dc0cc-3558-4db6-90c7-2f2c40a7b609","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"2,0","systemVersion":"1"},{"title":"K2_Breni_HowToInject_video script_BEFR","uuid":"1d88c19d-8b9b-4a86-b8d1-78e65ddf0524","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Breni_HowToInject_video script_BEDU","uuid":"c5953563-8754-466c-9f9b-deb042f4afe3","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Flyer_BEFR","uuid":"05f0001b-f56f-43e0-aa68-6a92de67d303","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment material_Flyer_BEDU","uuid":"c7d1d2ae-50e2-46d4-87d1-38aeb0226106","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment material_Poster_BEFR","uuid":"a6336d04-9c9b-488c-80d8-7f112fd9a08e","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment material_Poster_BEDU","uuid":"3d21ec5c-5a16-4820-afce-6c182e9d3fd1","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment material_Neuro alcohol use disorder_BEDU","uuid":"11957ba4-873f-41bd-8b65-25cd881b5c75","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Neuro alcohol use disorder_BEFR","uuid":"087495f8-ea1b-4299-9334-d0bc7aafe884","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Retention material_ZoomHealth TOS_BEDU","uuid":"2c3a4337-5988-4094-be9c-595d3fb2de2a","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Retention material_ZoomHealth TOS_BEFR","uuid":"c75cf324-b263-477e-8e1b-2945fa86debe","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Retention material_ZoomHealth TOS_ENG","uuid":"90b730eb-cb69-41e9-9c37-c77e8eead7b9","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Retention material_ZoomHealth Screenshots_BEFR","uuid":"4d2d4a6c-8885-4d26-9290-2499b8e3a953","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Retention material_ZoomHealth Screenshots_BEDU","uuid":"5d3d2e43-3844-4f7f-a139-e239179cbbb3","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Retention material_ZoomHealth Privacy Statement_ENG","uuid":"2749f0e9-5d0e-4721-85df-7b5b780ba4a5","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_Secondary Assessment_BEDU_Redacted","uuid":"ef294b92-82f7-4bee-a5e4-56b8f6a5b83b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"2"},{"title":"K2_Recruitment material_Trialbee_Secondary Assessment_BEFR_Redacted","uuid":"0704574a-a0b3-4b79-b919-e71631805dd5","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"2"},{"title":"K2_Recruitment material_Trialbee_Self-Assessment_BEDU_Redacted","uuid":"c73bc903-bbe1-4ca9-bea1-b36467bed981","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"2"},{"title":"K2_Recruitment material_Trialbee_Self-Assessment_BEFR_Redacted","uuid":"b6317ce8-58a1-44c8-84d8-38952dac08cf","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"2"},{"title":"K2_Recruitment material_Lilly-Trials_Trial-Page_BEDU","uuid":"50062f49-f592-45c6-a26c-aaaa8f727855","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Lilly-Trials_Trial-Page_BEFR","uuid":"2e8f3cd2-44db-413b-aa2d-577290645593","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_Global Privacy Policy_BEDU","uuid":"1abd8996-1a77-4411-b930-2b715666546b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_Global Privacy Policy_BEFR","uuid":"571e3612-596b-412b-afcb-4e6e879099fe","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_OverviewSupplementaryInformation_BEDU","uuid":"95948fd1-ee21-46aa-9075-8392e306a0ff","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_OverviewSupplementaryInformation_BEFR","uuid":"da6180c3-f8e9-4c03-97da-40ef25c37da6","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_Animated video storyboard_BEFR","uuid":"28a339e7-68be-47cd-ac56-2b9c886f2e98","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_Animated video storyboard_BEDU","uuid":"fb57961a-cc7b-4b89-a734-d3cc06ca49f8","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_Digital Marketing Content_BEFR","uuid":"6749b84b-8068-4787-9ae5-51dd3dfd3149","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment material_Trialbee_Digital Marketing Content_BEDU","uuid":"1d4a6f2b-3a34-480c-8d69-34fc82dc9541","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"L2_Other subject information material_Patient-facing landing page_Redacted_BEFR","uuid":"99e0dce1-2d74-4c40-9e7f-c7d25bf60bcc","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"1"},{"title":"L2_Other subject information material_Patient-facing landing page_Redacted_BEDU","uuid":"975fccf6-51dc-4c38-8145-533c7e8c46ca","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"1"},{"title":"L2_Other subject information material_Patient-facing landing page_Redacted_ENG","uuid":"691ce295-cc39-4853-a130-46fe708aa4c2","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"1"},{"title":"L2_Other subject information material_IQVIA eConsent Privacy Policy_BEDU","uuid":"e17df10b-788b-4d8b-b77a-d8b1bc67d650","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"L2_Other subject information material_IQVIA eConsent Privacy Policy_ENG","uuid":"957339ce-caee-4591-a038-7431f97aaf6f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"L2_Other subject information material_IQVIA eConsent Privacy Policy_BEFR","uuid":"af495233-0860-4cc5-a1c9-c040fc24ea7b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_BEDU","uuid":"ba9713ad-5c87-40ce-9cc7-8993b4a5b16a","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.4","systemVersion":"1"},{"title":"L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_EN","uuid":"8bd21e3a-ed04-436c-a2a9-14f8d1050d32","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.4","systemVersion":"1"},{"title":"L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_BEFR","uuid":"36d89774-4f52-453f-b4a3-64cd3bb3f9a8","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.4","systemVersion":"1"},{"title":"L1_SIS and ICF Main_ENG_Redacted","uuid":"1a6aed3d-59f9-4bda-972d-fd6510148d3a","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"L1_SIS and ICF Main_BEFR_Redacted","uuid":"f55b4fd2-e896-4395-9983-a471bdbf2a9d","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"L1_SIS and ICF Main_BEDU_Redacted","uuid":"4282f843-a904-4f4d-9eae-a5cd6375736a","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.2","systemVersion":"3"},{"title":"L2_Other Subject Information_Compensation Information Sheet_BEFR_Redacted","uuid":"c5313eb4-ea34-4817-97cf-ace32ce579dc","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"L2_Other Subject Information_Compensation Information Sheet_ENG_Redacted","uuid":"6f7f21e1-faf9-48ad-b6c9-99a4f3ff142f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"L2_Other subject information material_IFU_Brenipatide_BEDU_Redacted","uuid":"24a3abc9-428c-4ae9-b6ac-d2b61588a93f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"2.0","systemVersion":"1"},{"title":"L2_Other subject information material_IFU_Brenipatide_BEFR_Redacted","uuid":"e68fd49d-2ce4-4276-8c28-a7c43f15b98e","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"2.0","systemVersion":"1"},{"title":"L2_Other Subject Information_Compensation Information Sheet_BEDU_Redacted","uuid":"d889cdce-0687-4aff-a4f1-ea5790217c13","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.1","systemVersion":"2"},{"title":"L2_Other Subject information material_ICF Sponsor Statement_ENG_Redacted","uuid":"2bc8c4c2-e94b-4ef2-b416-86d269aab814","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1.0","systemVersion":"1"},{"title":"L2_Other Subject Information_IRB Notification Letter_IQVIA 8.0.1","uuid":"abbb4d43-4ed1-4311-bccd-612730512192","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":318003,"manualVersion":"1","systemVersion":"1"},{"title":"D4_Patient Facing Documents_copyright statement","uuid":"8fd721d7-01fa-40c0-bc88-4c006f4fa6f8","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":137719,"manualVersion":"1","systemVersion":"1"},{"title":"D1_Protocol 2025-522312-16-00_GZMP_Redacted","uuid":"ce3ae924-ae00-4457-bf41-f416e4aaf4e6","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":137719,"manualVersion":"c","systemVersion":"2"},{"title":"D1_Protocol Synopsis_BEDU_2025-522312-16-00_Redacted","uuid":"772f4445-3516-4323-b3c2-063443a2218f","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":137719,"manualVersion":"c","systemVersion":"2"},{"title":"D1_Protocol Synopsis_BEDE_2025-522312-16-00_Redacted","uuid":"f187d630-2308-40c8-a690-76805e7c2e30","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":28,"fileType":"PDF","associatedEntityId":137719,"manualVersion":"c","systemVersion":"2"},{"title":"D1_Protocol Synopsis_BEFR_2025-522312-16-00_Redacted","uuid":"6b9965e0-3328-4a04-945d-504d976edd74","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":137719,"manualVersion":"c","systemVersion":"2"},{"title":"D1_Protocol Synopsis_EN_2025-522312-16-00_Redacted","uuid":"6dfa2f97-c815-4808-8f30-0ebb9964180a","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":137719,"manualVersion":"c","systemVersion":"2"},{"title":"K1_Recruitment Arrangements","uuid":"40113043-b6b5-49c8-b14e-e7ed96f31f4f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Prescreening_tool_questions 2_Pratia Germany","uuid":"ca2bc0a1-f874-464a-a701-94eb4c4c3d38","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Prescreening_tool_questions_Pratia Germany","uuid":"be416d18-540e-406e-97c7-481f527dd161","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Letter-Doctor-to-Patient_Redacted","uuid":"da9dce4f-2be6-43ea-9656-1e3aef8a0f1b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Landing_Page_ZI_Mannheim","uuid":"0a645f5a-f7c7-4091-aa33-661e2a94bbe7","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_ Advertisement_Pratia Germany","uuid":"cfe62542-2ce5-4c38-9ea0-7169bcbe6097","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Recruitment texts_FutureMeds_Berlin","uuid":"88135e85-d383-4fc8-8b0d-d5bf26e5f070","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1.2","systemVersion":"1"},{"title":"K2 Recruitment Material_Recruitment texts_FutureMeds_Offenbach","uuid":"413348fa-7be1-4c88-910d-568e83759656","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1.2","systemVersion":"1"},{"title":"K2_Recruitment Material_Flyer_Master","uuid":"8399e0bd-e83f-423b-bf2a-bda35f89375b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_What-Is-A-Placebo_Master","uuid":"c7a5ad50-94f0-42dd-8b65-3d8977b434c6","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Poster_Master","uuid":"fcbcddd4-198a-4c7a-90e3-2203e4283705","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Neuro_Alcohol-Use-Disorder","uuid":"14516043-b24c-438c-919d-a13566b26109","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Brochure_Master_Redacted","uuid":"689571c1-0861-4e52-9a2f-682d1e4721e3","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Facebook-Ads ZI Mannheim","uuid":"c1885fd3-1509-41f5-8901-a59ab8bb1f05","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Breni_HowToInject_video script","uuid":"6b7cbb4b-77e0-4642-9f82-bff108f786bf","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"2","systemVersion":"1"},{"title":"K2_Recruitment and Retention_Trialbee_Global Privacy Policy","uuid":"5acd5c47-4b22-48d1-b237-bd736e4c1a62","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment and Retention_Animated video storyboard","uuid":"1d70bf26-c755-40aa-a06b-06c2f1918775","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment and Retention_Trialbee_Overview Supplementary Information","uuid":"100d1e64-a998-4525-a8f4-ee4501dc0aeb","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment and Retention_Trialbee_Digital Marketing Content","uuid":"77dff474-7ebb-4ad5-80e7-84b5c2ea8bf9","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment and Retention_Lilly Trials Landing Page","uuid":"54a39bd3-d0dd-46fe-8a0c-97cc24e1af50","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment and Retention_Trialbee_Secondary Assessment_Redacted","uuid":"b3d0505f-34e4-416c-ac78-594773b3b571","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1.1","systemVersion":"1"},{"title":"K2_Recruitment and Retention_Trialbee_Self-Assessment_Redacted","uuid":"d50bca21-5606-42b3-a9d7-2204333e2cab","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"1.1","systemVersion":"1"},{"title":"L1_SIS and ICF Main_Redacted","uuid":"f28f5206-0b98-44b4-9aec-98cd665c4ac8","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":324384,"manualVersion":"3.0","systemVersion":"4"}],"trialRegion":"Both","trialRegionCode":3,"correctiveMeasures":[]}