{"ctNumber":"2024-517598-26-00","ctStatus":"Ended","startDateEU":"2019-08-26","endDateEU":"2025-08-13","decisionDate":"2024-10-21T10:21:09.073","publishDate":"2026-08-11T03:31:11.227576637","ctPublicStatusCode":8,"authorizedApplication":{"authorizedPartI":{"id":52348,"rowSubjectCount":0,"products":[{"id":225513,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11019028","productPharmForm":"INTRAVENOUS INFUSION SOLUTION","euMpNumber":"PRD10683437","marketingAuthNumber":"PA1968/018/001","prodAuthStatus":2,"prodName":"0.9% Sodium Chloride Intravenous Infusion Solution","pharmForm":"SOLUTION FOR INFUSION","activeSubstanceName":"SODIUM CHLORIDE","euSubstNumber":"SUB12581MIG","authorisationCountryCode":"IE","mrpNumber":"IE/H/0729/001","nameOrg":"LABORATOIRE AGUETTANT","productSubstances":[{"productPk":"11019028","substancePk":"365109","nameOrg":"LABORATOIRE AGUETTANT","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"SODIUM CHLORIDE","substanceEvCode":"SUB12581MIG"}],"atcCode":"B05XA03","atcName":"SODIUM CHLORIDE","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"3","orphanDrugEdit":false,"doseUom":"millilitre(s)/kilogram","maxDailyDoseAmount":"40","doseUomTotal":"millilitre(s)/kilogram","maxTotalDoseAmount":"40","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD10683437","devices":[],"characteristics":[],"routes":["INTRAVENOUS INFUSION"],"allSubstancesChemicals":true,"productName":"0.9% Sodium Chloride Intravenous Infusion Solution","jsonActiveSubstanceNames":"sodium chloride","pharmaceuticalFormDisplay":"SOLUTION FOR INFUSION"},{"id":225500,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11593128","productPharmForm":"SOLUTION FOR INFUSION","euMpNumber":"PRD11593128","prodAuthStatus":1,"prodName":"Acyl Ghrelin 0.25 mg","pharmForm":"SOLUTION FOR INFUSION","activeSubstanceName":"LENOMORELIN","euSubstNumber":"SUB189223","nameOrg":"REGION OESTERGOETLAND","productSubstances":[{"productPk":"11593128","substancePk":"352552","nameOrg":"REGION OESTERGOETLAND","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LENOMORELIN","substanceEvCode":"SUB189223","synonyms":["GHRELIN","ACYL-GHRELIN","SUN11031"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"µg/Kg microgram(s)/kilogram","maxDailyDoseAmount":"4.1","doseUomTotal":"µg/Kg microgram(s)/kilogram","maxTotalDoseAmount":"4.1","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"hormone","evCode":"PRD11593128","devices":[],"characteristics":["11"],"routes":["INTRAVENOUS INFUSION"],"allSubstancesChemicals":false,"productName":"Acyl Ghrelin 0.25 mg","jsonActiveSubstanceNames":"lenomorelin","pharmaceuticalFormDisplay":"SOLUTION FOR INFUSION"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers","fullTitleTranslations":[],"publicTitle":"Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers","publicTitleTranslations":[],"shortTitle":"GHREDECIDE","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"This is an exploratory experimental medicine study to examine effects of ghrelin on behaviors of relevance for gambling.","trialCategoryId":48204},"medicalCondition":{"partIMedicalConditions":[{"id":55570,"medicalCondition":"Gambling disorder","medicalConditionTranslations":[],"isConditionRareDisease":false}]},"trialObjective":{"trialScopes":[{"code":"13","otherDescription":"exploratory","trialScopeId":159345}],"mainObjective":"Study 1: The primary objective of this protocol is to investigate whether IV ghrelin will alter decision making processes including those that involve a) evaluation of reward; b) propensity to take on risk; c) trading off of small immediate rewards vs larger, temporally more distant ditto (delay discounting), and d) goal-directed learning; as well as the neural substrates associated with these decision making processes, measured using fMRI. \n\nStudy 2: The primary objective of the protocol is to investigate whether IV ghrelin will affect sensitivity to losses in a gambling environment.","mainObjectiveTranslations":[],"secondaryObjectives":[{"id":179746,"number":1,"secondaryObjective":"assess measures of risk aversion using an established Prospect Theory gambling task","secondaryObjectiveTranslations":[]},{"id":179747,"number":2,"secondaryObjective":"assess risk taking using the BART (Balloon Analogue Risk Task)","secondaryObjectiveTranslations":[]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":346036,"number":1,"principalInclusionCriteria":"Age 18-65 years.","principalInclusionCriteriaTranslations":[]},{"id":346037,"number":2,"principalInclusionCriteria":"Good health as determined by medical history, ECG and clinical assessment of lab tests. Lab tests will include sodium, potassium, creatinine, hemoglobin, EVF, erythrocytes, leukocytes, platelets, MCV, MCH, MCHC, albumin, bilirubin, plasma lipids, ALP, ASAT, ALAT, CRP, GT. The final decision will be according to the judgment of the investigator.","principalInclusionCriteriaTranslations":[]},{"id":346038,"number":3,"principalInclusionCriteria":"Creatinine ≤ 176 µmol/L.","principalInclusionCriteriaTranslations":[]},{"id":346039,"number":4,"principalInclusionCriteria":"Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.","principalInclusionCriteriaTranslations":[]},{"id":346040,"number":5,"principalInclusionCriteria":"Participant must be willing to receive two IV lines.","principalInclusionCriteriaTranslations":[]},{"id":346041,"number":6,"principalInclusionCriteria":"Inclusion criteria specific for study 1   Participant must be willing to undergo an MR scan.","principalInclusionCriteriaTranslations":[]},{"id":346042,"number":7,"principalInclusionCriteria":"nclusion criteria specific for study 2    Proficiency in Swedish.","principalInclusionCriteriaTranslations":[]}],"principalExclusionCriteria":[{"id":596812,"number":1,"principalExclusionCriteria":"Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.","principalExclusionCriteriaTranslations":[]},{"id":596813,"number":2,"principalExclusionCriteria":"Specific exclusion criteria related to the administration of ghrelin are chronic inflammatory diseases (e.g., Crohn’s disease, ulcerative colitis, celiac disease), diabetes, obesity (BMI ≥ 30 kg/m2), weight ≥ 120 kg, high triglycerides level (> 4,0 mmol/l), history of clinically significant hypotension (e.g., history of fainting and/or syncopal attacks) and/or resting systolic BP < 100 mmHg.","principalExclusionCriteriaTranslations":[]},{"id":596814,"number":3,"principalExclusionCriteria":"Any use of CNS-active medications.","principalExclusionCriteriaTranslations":[]},{"id":596815,"number":4,"principalExclusionCriteria":"Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).","principalExclusionCriteriaTranslations":[]},{"id":596816,"number":5,"principalExclusionCriteria":"Pregnancy, intention to become pregnant, or breastfeeding a child.","principalExclusionCriteriaTranslations":[]},{"id":596817,"number":6,"principalExclusionCriteria":"Exclusion criteria specific for study 1   Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine; any history of a past eating disorder, psychotic illness, or bipolar disorder; as determined by medical history, and MINI interview carried out by appropriately trained staff.","principalExclusionCriteriaTranslations":[]},{"id":596818,"number":7,"principalExclusionCriteria":"Exclusion criteria specific for study 1 Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.","principalExclusionCriteriaTranslations":[]},{"id":596819,"number":8,"principalExclusionCriteria":"Exclusion criteria specific for study 2    Any current clinically significant psychiatric problems including a DSM-5 diagnosis of severe Substance Use Disorder other than nicotine, or Gambling Disorder. Patients will be screened using the Modified MINI Screen [MMS], the Alcohol Use Disorder Identification Test [AUDIT], the Drug Use Disorder Identification Test (DUDIT] and the NORC Diagnostic Screen for Gambling Problems [NODS]. The results and their clinical significance will be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If an indication is obtained that a clinically significant psychiatric disorder may be present, a full structured diagnostic interview [MINI] will be carried out by appropriately trained staff prior to determining eligibility.","principalExclusionCriteriaTranslations":[]},{"id":596820,"number":9,"principalExclusionCriteria":"Exclusion criteria specific for study 2  Any lifetime history of problematic gambling.","principalExclusionCriteriaTranslations":[]}]},"endPoint":{"primaryEndPoints":[{"id":400868,"number":1,"endPoint":"The dependent variable will be the total number of spins the participant carries out in the Slot Machine task.","isPrimary":true,"endPointTranslations":[]}],"secondaryEndPoints":[{"id":400869,"number":1,"endPoint":"The dependent variable will be the proportion of trials in which the participant gambled, i.e.; chose the option with an uncertain over that with a certain outcome in the Gambling Task.","isPrimary":false,"endPointTranslations":[]},{"id":400870,"number":2,"endPoint":"The dependent variable will be the mean number of pumps per trial, excluding trials where the balloon explodes in the Balloon Analog Risk Task..","isPrimary":false,"endPointTranslations":[]}]},"trialDuration":{"estimatedEndDate":"2025-12-30","estimatedRecruitmentStartDate":"2024-03-26"},"sourceOfMonetarySupport":[],"populationOfTrialSubjects":{"ageRanges":[{"id":149957,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"1","name":"Healthy volunteers"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{"planToShareIPD":"1","planDescription":"De-identified IPD sharing are widely accepted, as it allows addressing issues concerning trial publication (e.g., nonpublication, selective reporting, lack of reproducibility), validation or correction of articles, and the conduct of IPD meta-analyses."}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-10-21","conclusionDate":"2024-10-21","therapeuticAreas":[{"code":"31","name":"Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]"},{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"},{"code":"18","name":"Diseases [C] - Nutritional and Metabolic Diseases [C18]"}],"medicalConditions":[{"id":55570,"medicalCondition":"Gambling disorder","isConditionRareDisease":false}],"sponsors":[{"id":55272,"primary":true,"publicContacts":[{"id":174520,"type":"Public","functionalName":"Markus Heilig","functionalEmailAddress":"markus.heilig@liu.se","telephone":"+46700850769","organisation":{"id":607468,"type":"Educational Institution","typeCode":"1","name":"Linkopings Universitet","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100028963","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":174521,"type":"Scientific","functionalName":"Markus Heilig","functionalEmailAddress":"markus.heilig@liu.se","telephone":"+46700850769","organisation":{"id":607468,"type":"Educational Institution","typeCode":"1","name":"Linkopings Universitet","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100028963","organisationLocationStatus":"Active"}}],"thirdParties":[],"organisation":{"id":607468,"type":"Educational Institution","typeCode":"1","name":"Linkopings Universitet","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100028963","organisationLocationStatus":"Active"},"addresses":[{"id":574760,"organisation":{"id":607468,"type":"Educational Institution","typeCode":"1","name":"Linkopings Universitet","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100028963","organisationLocationStatus":"Active"},"address":{"addressId":619506,"oneLine":"Sandbacksgatan 7, Linkopings Domkyrkofors.","addressLine1":"Sandbacksgatan 7","addressLine2":"Linkopings Domkyrkofors.","addressLine3":"","addressLine4":"","city":"Linkoping","postcode":"582 25","country":2028,"countryName":"Sweden"},"phone":"13281000","isBusinessKeyValidated":true,"businessKey":"ORG-100028963"}],"isCommercial":false,"commercial":"Non-Commercial"}],"trialCategoryCode":"2","trialCategoryJustificationComment":"This is an exploratory experimental medicine study to examine effects of ghrelin on behaviors of relevance for gambling.","partOneTherapeuticAreas":[{"id":628032,"therapeuticArea":{"code":"31","name":"Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]"}},{"id":628033,"therapeuticArea":{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"}},{"id":628034,"therapeuticArea":{"code":"18","name":"Diseases [C] - Nutritional and Metabolic Diseases [C18]"}}],"productRoleGroupInfos":[{"id":175004,"comments":"0.9% Sodium Chloride Intravenous Infusion Solution","productRoleCode":"3","productRoleName":"Placebo","products":[{"id":225513,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11019028","productPharmForm":"INTRAVENOUS INFUSION SOLUTION","euMpNumber":"PRD10683437","marketingAuthNumber":"PA1968/018/001","prodAuthStatus":2,"prodName":"0.9% Sodium Chloride Intravenous Infusion Solution","pharmForm":"SOLUTION FOR INFUSION","activeSubstanceName":"SODIUM CHLORIDE","euSubstNumber":"SUB12581MIG","authorisationCountryCode":"IE","mrpNumber":"IE/H/0729/001","nameOrg":"LABORATOIRE AGUETTANT","productSubstances":[{"productPk":"11019028","substancePk":"365109","nameOrg":"LABORATOIRE AGUETTANT","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"SODIUM CHLORIDE","substanceEvCode":"SUB12581MIG"}],"atcCode":"B05XA03","atcName":"SODIUM CHLORIDE","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"3","orphanDrugEdit":false,"doseUom":"millilitre(s)/kilogram","maxDailyDoseAmount":"40","doseUomTotal":"millilitre(s)/kilogram","maxTotalDoseAmount":"40","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD10683437","devices":[],"characteristics":[],"routes":["INTRAVENOUS INFUSION"],"allSubstancesChemicals":true,"productName":"0.9% Sodium Chloride Intravenous Infusion Solution","jsonActiveSubstanceNames":"sodium chloride","pharmaceuticalFormDisplay":"SOLUTION FOR INFUSION"}]},{"id":175003,"comments":"Acyl Ghrelin 0.25 mg","productRoleCode":"1","productRoleName":"Test","products":[{"id":225500,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11593128","productPharmForm":"SOLUTION FOR INFUSION","euMpNumber":"PRD11593128","prodAuthStatus":1,"prodName":"Acyl Ghrelin 0.25 mg","pharmForm":"SOLUTION FOR INFUSION","activeSubstanceName":"LENOMORELIN","euSubstNumber":"SUB189223","nameOrg":"REGION OESTERGOETLAND","productSubstances":[{"productPk":"11593128","substancePk":"352552","nameOrg":"REGION OESTERGOETLAND","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LENOMORELIN","substanceEvCode":"SUB189223","synonyms":["GHRELIN","ACYL-GHRELIN","SUN11031"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"µg/Kg microgram(s)/kilogram","maxDailyDoseAmount":"4.1","doseUomTotal":"µg/Kg microgram(s)/kilogram","maxTotalDoseAmount":"4.1","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"hormone","evCode":"PRD11593128","devices":[],"characteristics":["11"],"routes":["INTRAVENOUS INFUSION"],"allSubstancesChemicals":false,"productName":"Acyl Ghrelin 0.25 mg","jsonActiveSubstanceNames":"lenomorelin","pharmaceuticalFormDisplay":"SOLUTION FOR INFUSION"}]}],"isLowIntervention":false},"authorizedPartsII":[{"id":132502,"mscId":38558,"mscInfo":{"id":38558,"clinicalTrialId":18700,"countryOrganisationId":2028,"reportingStatusCode":"Ended","fromDate":"2024-08-29","toDate":"2024-08-29","isProposedRms":true,"countryName":"Sweden","organisationInfo":{},"firstDecisionDate":"2024-10-21","trialStatus":"Ended","trialPeriod":[{"id":51440,"trialStartDate":"2019-08-26","fromDate":"2025-02-27"},{"id":52689,"trialStartDate":"2019-08-26","fromDate":"2025-03-17"},{"id":51439,"trialStartDate":"2022-04-20","fromDate":"2025-02-27"},{"id":51441,"trialStartDate":"2022-04-20","fromDate":"2025-02-27"},{"id":51442,"trialStartDate":"2022-04-20","fromDate":"2025-02-27"},{"id":53027,"trialStartDate":"2019-08-26","fromDate":"2025-03-20"},{"id":53028,"trialStartDate":"2019-08-26","fromDate":"2025-03-20"},{"id":64441,"trialStartDate":"2019-08-26","trialEndDate":"2025-08-13","fromDate":"2025-09-16"}],"trialRecruitmentPeriod":[{"id":68817,"recruitmentStartDate":"2022-04-22","fromDate":"2025-02-27"},{"id":68818,"recruitmentStartDate":"2022-04-22","fromDate":"2025-02-27"},{"id":71201,"recruitmentStartDate":"2019-08-28","fromDate":"2025-03-20"},{"id":71202,"recruitmentStartDate":"2019-08-28","fromDate":"2025-03-20"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":97854,"trialStartDate":"2019-08-26","trialEndDate":"2025-08-13","fromDate":"2025-03-20","isBenefitRiskBalanceTemporaryHalt":false,"isBenefitRiskBalanceEndTrail":false,"isTemporaryHalt":false,"isEndTrial":true},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2019-08-28"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":57982,"mscId":38558,"trialStatus":"Authorised","trialStatusDate":"2024-10-21T10:21:08.845"},{"id":55735,"mscId":38558,"trialStatus":"Under evaluation","trialStatusDate":"2024-10-08T09:33:08.316"},{"id":92350,"mscId":38558,"trialStatus":"Ended","trialStatusDate":"2025-09-16T08:55:11.695"}],"applicationTypeMsc":"1","mscName":"Sweden","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-10-21","decision":"authorized","decisionDate":"2024-10-21"},"decisionDate":"2024-10-21","recruitmentSubjectCount":74,"trialSites":[{"id":915533,"organisationAddressInfo":{"id":602486,"organisation":{"id":635362,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Region Oestergoetland","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100010599","organisationLocationStatus":"Active"},"address":{"addressId":650554,"oneLine":"Universitetssjukhuset I","addressLine1":"Universitetssjukhuset I","addressLine2":"","addressLine3":"","addressLine4":"","city":"Linkoping","postcode":"58185","country":2028,"countryName":"Sweden"},"phone":"+46700850769","email":"markus.heilig@liu.se","isBusinessKeyValidated":true,"businessKey":"ORG-100010599"},"personInfo":{"id":1021564,"firstName":"Markus","lastName":"Heilig","telephone":"+46700850769","email":"markus.heilig@liu.se","title":"2"},"departmentName":"Psykiatriska kliniken"}],"applicationStatusCode":"Authorised"}],"applicationInfo":[{"id":34267,"type":"INITIAL","status":"Authorised","ctNumber":"2024-517598-26-00","trialStatus":"Ended","submissionDate":"2024-10-08","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-10-21"},"partIIInfo":[{"id":132502,"mscId":38558,"mscInfo":{"id":38558,"mscName":"Sweden","countryOrganisationId":2028,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-10-21","decision":"authorized","decisionDate":"2024-10-21","reportingStatusCode":"Ended","countryName":"Sweden","trialStatus":"Ended","firstDecisionDate":"2024-10-21"},"applicationStatusCode":"Authorised"}],"decisionDate":"2024-10-21","ctMSCsByApplication":[{"id":38558,"mscName":"Sweden","reportingStatusCode":"Ended"}],"businessKey":"IN","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":42713,"applicationId":34267,"mscId":38558,"mscName":"Sweden","decisionDate":"2024-10-21T10:21:09.073","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":132502,"part1Id":52348,"applicationType":"INITIAL","isRMS":true}]}],"trialGlobalEnd":[],"memberStatesConcerned":[{"mscName":"Sweden","mscId":38558,"firstDecisionDate":"2024-10-21T10:21:09.073","lastDecisionDate":"2024-10-21T10:21:09.073","mscPublicStatusCode":8}],"eudraCt":{"isTransitioned":true,"eudraCtCode":"2018-004829-82"}},"events":{"temporaryHaltList":[],"trialEvents":[{"mscId":38558,"mscName":"Sweden","events":[{"notificationType":"START_OF_TRIAL","date":"2019-08-26"},{"notificationType":"END_OF_TRIAL","date":"2025-08-13"},{"notificationType":"START_OF_RECRUITMENT","date":"2019-08-28"}]}],"unexpectedEvents":[],"seriousBreaches":[],"urgentSafetyMeasures":[]},"results":{"summaryResults":[{"id":7780,"ctNumber":"2024-517598-26-00","title":"Summary of results","status":"Submitted","summaryType":"Summary of Results","versionType":"Final","isFinalResult":true,"notificationId":147070,"updatedOn":"2026-08-10T10:10:28.03047","createdOn":"2026-08-10T10:10:23.278","submissionDate":"2026-08-10T10:10:28","ctId":18700,"businessKey":"SUM-147068"}],"laypersonResults":[{"id":7779,"ctNumber":"2024-517598-26-00","title":"Layperson summary of results","status":"Submitted","summaryType":"Laypersons Summary of Results","versionType":"Final","isFinalResult":true,"notificationId":147069,"updatedOn":"2026-08-10T10:10:08.435508","createdOn":"2026-08-10T10:09:59.284","submissionDate":"2026-08-10T10:10:08","ctId":18700,"businessKey":"SUM-147067"}]},"documents":[{"title":"20240607 Protokoll v32 clean","uuid":"ef96cdb7-1794-4247-a2fb-6b2b7393494c","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"DOCX","associatedEntityId":52348,"manualVersion":"1","systemVersion":"1"},{"title":"Annons Ghredecide","uuid":"39811406-b9de-493d-9980-23b15cd721bf","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":24,"fileType":"DOCX","associatedEntityId":132502,"manualVersion":"1","systemVersion":"1"},{"title":"2024 03 05 Forskningspersoninformation study 2","uuid":"546efdbd-3d19-4691-9abc-bb9e95ee34c8","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":24,"fileType":"DOCX","associatedEntityId":132502,"manualVersion":"1","systemVersion":"1"},{"title":"Popularvetenskaplig_sammanfattning_CTIS_Ghrelinstudien","uuid":"c2e59c9d-2d74-4503-b9e8-b91477afa8ab","documentType":"46","documentTypeLabel":"Laypersons summary of results (for publication)","languageCode":39,"fileType":"PDF","associatedEntityId":7779,"manualVersion":"1","systemVersion":"1"},{"title":"Summary of results","uuid":"6be5ef6d-6082-4c23-ac1a-320f72976bc3","documentType":"103","documentTypeLabel":"Summary of results (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":7780,"manualVersion":"1","systemVersion":"1"}],"trialRegion":"EEA","trialRegionCode":1,"correctiveMeasures":[]}