{"protocolSection":{"identificationModule":{"nctId":"NCT04311411","orgStudyIdInfo":{"id":"17223"},"secondaryIdInfos":[{"id":"I8F-MC-GPHH","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide in Overweight and Very Overweight Participants","officialTitle":"Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI"},"statusModule":{"statusVerifiedDate":"2024-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-08-24","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-12-16","type":"ACTUAL"},"completionDateStruct":{"date":"2022-12-16","type":"ACTUAL"},"studyFirstSubmitDate":"2020-03-16","studyFirstSubmitQcDate":"2020-03-16","studyFirstPostDateStruct":{"date":"2020-03-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-12-12","resultsFirstSubmitQcDate":"2024-05-21","resultsFirstPostDateStruct":{"date":"2024-05-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-05-21","lastUpdatePostDateStruct":{"date":"2024-05-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center."},"conditionsModule":{"conditions":["Obesity","Overweight"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","maskingDescription":"Tirzepatide and placebo dosing are double-blind. Liraglutide dosing is open label.","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":114,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide","type":"EXPERIMENTAL","description":"Participants received tirzepatide 5 milligrams (mg) once a week (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the subcutaneous (SC) tissue of the abdominal wall.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo administered into the SC tissue of the abdominal wall.","interventionNames":["Drug: Placebo"]},{"label":"Liraglutide","type":"ACTIVE_COMPARATOR","description":"Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.","interventionNames":["Drug: Liraglutide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC.","armGroupLabels":["Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC.","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Liraglutide","description":"Administered SC.","armGroupLabels":["Liraglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3","description":"Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.","timeFrame":"Baseline, Week 3"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas","description":"Change from baseline in BOLD fMRI signals in response to images of highly palatable foods (high fat-high sugar and high fat-high carbohydrate) relative to nonfood items during the fasting state in the brain reward areas (Insula, medial frontal gyrus, superior temporal gyrus, precentral gyrus, and cingulate gyrus) at Week 3 is reported. fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of viewing food images in each brain reward areas was measured by the signal change in BOLD response. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) model with covariates Baseline + Treatment + Baseline Body mass index (BMI) Stratum + Scanner Identification + Week + Treatment\\*Week + Participant + Random Error.","timeFrame":"Baseline, Week 3"},{"measure":"Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score","description":"The VAS determines the effects on appetite sensations and desire for specific foods. It consists of 8 individual questions that measure hunger, satiety, fullness, prospective food consumption, desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food. The VAS scales will be analyzed as continuous variables on the 0-100 scale for 8 individual components. Hunger, satiety, fullness, prospective food consumption are rated as 0=Not at all and 100=Extremely. Desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food are rated as 0=Yes, very much and 100=No, not at all. Overall appetite score is calculated as the average of the first 4 individual scores (satiety + fullness + \\[100-prospective food consumption\\] + \\[100-hunger\\]/4). The higher overall appetite score indicates less appetite, and the lower score indicates more appetite.","timeFrame":"Baseline, Week 3"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have stable body weight for the past 1 month prior to screening\n* Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening\n* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff\n* Women must not be pregnant or breastfeeding\n\nExclusion Criteria:\n\n* Have undergone or plan to undergo gastric bypass or bariatric surgery\n* Have claustrophobia or have ferromagnetic implants that can interfere with completion of fMRI measurements\n* Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study\n* Unwilling to comply with smoking and alcohol restrictions during the study\n* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening\n* Have a diagnosis of type 2 diabetes","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Indiana University School of Medicine","city":"Indianapolis","state":"Indiana","zip":"46202","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Pennington Biomedical Research Center","city":"Baton Rouge","state":"Louisiana","zip":"70808","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"Johns Hopkins University School of Medicine","city":"Baltimore","state":"Maryland","zip":"21287","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}}]},"referencesModule":{"references":[{"pmid":"40555748","type":"DERIVED","citation":"Martin CK, Carmichael OT, Carnell S, Considine RV, Kareken DA, Dydak U, Mattes RD, Scott D, Shcherbinin S, Nishiyama H, Knights A, Urva S, Biernat L, Pratt E, Haupt A, Mintun M, Otero Svaldi D, Milicevic Z, Coskun T. Tirzepatide on ingestive behavior in adults with overweight or obesity: a randomized 6-week phase 1 trial. Nat Med. 2025 Sep;31(9):3141-3150. doi: 10.1038/s41591-025-03774-9. Epub 2025 Jun 24."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide in Overweight and Very Overweight Participants","url":"https://trials.lillytrialguide.com/en-US/trial/3lm77tQ6Zi4YpYUnGE0fDr"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo administered into the subcutaneous (SC) tissue of the abdominal wall."},{"id":"FG001","title":"Tirzepatide","description":"Participants received tirzepatide 5 milligrams (mg) once weekly (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall."},{"id":"FG002","title":"Liraglutide","description":"Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"38"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"38"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"36"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who were randomized and received at least 1 dose of study drug.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received placebo administered into the SC tissue of the abdominal wall."},{"id":"BG001","title":"Tirzepatide","description":"Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall."},{"id":"BG002","title":"Liraglutide","description":"Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"114"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.2","spread":"9.5"},{"groupId":"BG001","value":"44.8","spread":"10.2"},{"groupId":"BG002","value":"43.7","spread":"11.9"},{"groupId":"BG003","value":"44.9","spread":"10.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"97"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"17"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"35"},{"groupId":"BG003","value":"108"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African 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States","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"114"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3","description":"Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.","populationDescription":"All randomized participants who received at least 1 dose of the placebo or tirzepatide and had evaluable data for this outcome measure.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilocalories (kcal)","timeFrame":"Baseline, Week 3","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered into the SC tissue of the abdominal wall."},{"id":"OG001","title":"Tirzepatide","description":"Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.95","spread":"49.06"},{"groupId":"OG001","value":"-523.15","spread":"52.78"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Median Difference (Final Values)","paramValue":"-534.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-668.20","ciUpperLimit":"-400.02"}]},{"type":"SECONDARY","title":"Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas","description":"Change from baseline in BOLD fMRI signals in response to images of highly palatable foods (high fat-high sugar and high fat-high carbohydrate) relative to nonfood items during the fasting state in the brain reward areas (Insula, medial frontal gyrus, superior temporal gyrus, precentral gyrus, and cingulate gyrus) at Week 3 is reported. fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of viewing food images in each brain reward areas was measured by the signal change in BOLD response. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) model with covariates Baseline + Treatment + Baseline Body mass index (BMI) Stratum + Scanner Identification + Week + Treatment\\*Week + Participant + Random Error.","populationDescription":"All randomized participants who received at least 1 dose of the study drug and had evaluable data. Overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed includes participants who were evaluable for the given categories.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Arbitrary Units","timeFrame":"Baseline, Week 3","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered into the SC tissue of the abdominal wall."},{"id":"OG001","title":"Tirzepatide","description":"Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall."},{"id":"OG002","title":"Liraglutide","description":"Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"31"}]}],"classes":[{"title":"Insula","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"31"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.0739","spread":"0.0740"},{"groupId":"OG001","value":"-0.0301","spread":"0.0771"},{"groupId":"OG002","value":"0.0190","spread":"0.0738"}]}]},{"title":"Medial frontal gyrus","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"31"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0504","spread":"0.0649"},{"groupId":"OG001","value":"0.0494","spread":"0.0680"},{"groupId":"OG002","value":"0.0581","spread":"0.0658"}]}]},{"title":"Superior temporal gyrus","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"31"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0132","spread":"0.0838"},{"groupId":"OG001","value":"0.0174","spread":"0.0881"},{"groupId":"OG002","value":"0.0621","spread":"0.0839"}]}]},{"title":"Precentral gyrus","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"31"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0441","spread":"0.0580"},{"groupId":"OG001","value":"0.0249","spread":"0.0616"},{"groupId":"OG002","value":"0.0845","spread":"0.0593"}]}]},{"title":"Cingulate gyrus","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"31"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0283","spread":"0.0615"},{"groupId":"OG001","value":"0.0214","spread":"0.0643"},{"groupId":"OG002","value":"0.0967","spread":"0.0623"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Insula","nonInferiorityType":"SUPERIORITY","pValue":"0.5437","statisticalMethod":"Mixed Models Analysis","paramType":"Median Difference (Final Values)","paramValue":"0.0439","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.0994","ciUpperLimit":"0.1871"},{"groupIds":["OG000","OG002"],"groupDescription":"Insula","nonInferiorityType":"SUPERIORITY","pValue":"0.1806","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"0.0930","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.0441","ciUpperLimit":"0.2301"},{"groupIds":["OG001","OG002"],"groupDescription":"Insula","nonInferiorityType":"SUPERIORITY","pValue":"0.4720","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.0491","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1846","ciUpperLimit":"0.0863"},{"groupIds":["OG000","OG001"],"groupDescription":"Medial frontal gyrus","nonInferiorityType":"SUPERIORITY","pValue":"0.9842","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.0011","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1079","ciUpperLimit":"0.1058"},{"groupIds":["OG000","OG002"],"groupDescription":"Medial frontal gyrus","nonInferiorityType":"SUPERIORITY","pValue":"0.8822","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final 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Values)","paramValue":"0.0404","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.0617","ciUpperLimit":"0.1425"},{"groupIds":["OG001","OG002"],"groupDescription":"Precentral gyrus","nonInferiorityType":"SUPERIORITY","pValue":"0.2488","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.0596","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1619","ciUpperLimit":"0.0426"},{"groupIds":["OG000","OG001"],"groupDescription":"Cingulate gyrus","nonInferiorityType":"SUPERIORITY","pValue":"0.8886","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.0070","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1059","ciUpperLimit":"0.0919"},{"groupIds":["OG000","OG002"],"groupDescription":"Cingulate gyrus","nonInferiorityType":"SUPERIORITY","pValue":"0.1563","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final 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It consists of 8 individual questions that measure hunger, satiety, fullness, prospective food consumption, desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food. The VAS scales will be analyzed as continuous variables on the 0-100 scale for 8 individual components. Hunger, satiety, fullness, prospective food consumption are rated as 0=Not at all and 100=Extremely. Desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food are rated as 0=Yes, very much and 100=No, not at all. Overall appetite score is calculated as the average of the first 4 individual scores (satiety + fullness + \\[100-prospective food consumption\\] + \\[100-hunger\\]/4). The higher overall appetite score indicates less appetite, and the lower score indicates more appetite.","populationDescription":"All randomized participants who received at least 1 dose of the study drug and had evaluable data. Overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed includes participants who were evaluable for the given categories.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 3","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered into the SC tissue of the abdominal wall."},{"id":"OG001","title":"Tirzepatide","description":"Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall."},{"id":"OG002","title":"Liraglutide","description":"Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"36"}]}],"classes":[{"title":"Fasting (Pre-lunch)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"31"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.15","spread":"3.02"},{"groupId":"OG001","value":"22.72","spread":"3.30"},{"groupId":"OG002","value":"8.78","spread":"3.11"}]}]},{"title":"Postprandial (Post-lunch)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"36"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.59","spread":"2.08"},{"groupId":"OG001","value":"1.66","spread":"2.23"},{"groupId":"OG002","value":"0.05","spread":"2.12"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Fasting (Pre-lunch)","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"20.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"12.11","ciUpperLimit":"29.02"},{"groupIds":["OG000","OG002"],"groupDescription":"Fasting (Pre-lunch)","nonInferiorityType":"SUPERIORITY","pValue":"0.1097","pValueComment":"Fasting","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"6.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.53","ciUpperLimit":"14.79"},{"groupIds":["OG001","OG002"],"groupDescription":"Fasting (Pre-lunch)","nonInferiorityType":"SUPERIORITY","pValue":"0.0015","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"13.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.49","ciUpperLimit":"22.38"},{"groupIds":["OG000","OG001"],"groupDescription":"Postprandial (Post-lunch)","nonInferiorityType":"SUPERIORITY","pValue":"0.4469","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"2.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.60","ciUpperLimit":"8.09"},{"groupIds":["OG000","OG002"],"groupDescription":"Postprandial (Post-lunch)","nonInferiorityType":"SUPERIORITY","pValue":"0.8227","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"0.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.02","ciUpperLimit":"6.31"},{"groupIds":["OG001","OG002"],"groupDescription":"Postprandial (Post-lunch)","nonInferiorityType":"SUPERIORITY","pValue":"0.5861","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"1.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.23","ciUpperLimit":"7.45"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to 10 Weeks","description":"All randomized participants who received at least 1 dose of the study drug. 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