protocolSection identificationModule nctId: NCT06373146, orgStudyIdInfo id: 18750, secondaryIdInfos id: I8F-MC-GPIV, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: The main purpose of this study is to determine if combining tirzepatide with the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 weeks and may include up to 19 visits., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Tirzepatide, interventions name: Mibavademab, interventions name: Tirzepatide-Placebo, interventions name: Mibavademab-Placebo, outcomesModule primaryOutcomes measure: Mean Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg), secondaryOutcomes measure: Mean Absolute Change from Baseline for Body Weight (kg), secondaryOutcomes measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction, secondaryOutcomes measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction, secondaryOutcomes measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction, secondaryOutcomes measure: Percentage of Participants Who Achieve ≥20 Body Weight Reduction, secondaryOutcomes measure: Mean Percent Change from Randomization 2 for Body Weight, secondaryOutcomes measure: Mean Change from Randomization 2 for Body Weight (kg), secondaryOutcomes measure: Mean Absolute Change from Randomization 2 for Body Weight (kg), secondaryOutcomes measure: Change from Baseline to Week 24 in CoEQ Scores, secondaryOutcomes measure: Change from Baseline to Week 24 in CoEQ Scores, secondaryOutcomes measure: Change from Baseline in FCQ-T-r Scores, secondaryOutcomes measure: Change from Baseline in FCQ-T-r Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clinical Research, Gardena, city: Gardena, state: California, zip: 90247, country: United States, contacts name: Mark T. Leibowitz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.88835, lon: -118.30896, locations facility: Irvine Clinical Research, city: Irvine, state: California, zip: 92614, country: United States, contacts name: Elly R Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.66946, lon: -117.82311, locations facility: National Research Institute - Wilshire, city: Los Angeles, state: California, zip: 90057, country: United States, contacts name: Juan Pablo Frias, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Velocity Clinical Research, North Hollywood, city: North Hollywood, state: California, zip: 91606, country: United States, contacts name: Samuel Penziner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.17223, lon: -118.37897, locations facility: Velocity Clinical Research, Panorama City, city: Panorama City, state: California, zip: 91402, country: United States, contacts name: Maricor Grio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.22473, lon: -118.44981, locations facility: Velocity Clinical Research, Santa Ana, city: Santa Ana, state: California, zip: 92704, country: United States, contacts name: Julie Vu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Diablo Clinical Research, Inc., city: Walnut Creek, state: California, zip: 94598, country: United States, contacts name: Bonnie S. Kimmel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.90631, lon: -122.06496, locations facility: Solaris Clinical Research, city: Meridian, state: Idaho, zip: 83646, country: United States, contacts name: David J. Butuk, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61211, lon: -116.39151, locations facility: Tandem Clinical Research, city: Marrero, state: Louisiana, zip: 70072, country: United States, contacts name: Adil Fatakia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.89937, lon: -90.10035, locations facility: Velocity Clinical Research, Metairie, city: Metairie, state: Louisiana, zip: 70006, country: United States, contacts name: Scott P Striplin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Velocity Clinical Research, Norfolk, city: Norfolk, state: Nebraska, zip: 68701, country: United States, contacts name: Charles Harold Harper, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.02834, lon: -97.417, locations facility: Lillestol Research, city: Fargo, state: North Dakota, zip: 58104, country: United States, contacts name: Michael J Lillestol, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.87719, lon: -96.7898, locations facility: South Texas Clinical Research, city: Corpus Christi, state: Texas, zip: 78404, country: United States, contacts name: Lloyd Stegemann, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.80058, lon: -97.39638, locations facility: Dallas Diabetes Research Center, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Julio Rosenstock, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Northwest Clinical Research Center, city: Bellevue, state: Washington, zip: 98007, country: United States, contacts name: Nazia Rahman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.61038, lon: -122.20068, locations facility: Centro de Investigacion en Artritis y Osteoporosis SC, city: Mexicali, state: Baja California, zip: 21200, country: Mexico, contacts name: Francisco Fidencio Cons Molina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.62781, lon: -115.45446, locations facility: Clínicos Asociados BOCM, city: Mexico City, state: Distrito Federal, zip: 03300, country: Mexico, contacts name: Israel Olvera-Alvarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Unidad biomedica avanzada monterrey, city: Monterrey, state: Nuevo León, zip: 64460, country: Mexico, contacts name: Raymundo Garcia Reza, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Medical Care and Research SA de CV, city: Merida, state: Yucatán, zip: 97070, country: Mexico, contacts name: Carlos Eduardo Medina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.97537, lon: -89.61696, locations facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos, city: Chihuahua, zip: 31110, country: Mexico, contacts name: Luis Alejandro Nevarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.63528, lon: -106.08889, hasResults: False