{"protocolSection":{"identificationModule":{"nctId":"NCT06771115","orgStudyIdInfo":{"id":"VTX3232-204"},"secondaryIdInfos":[{"id":"J7V-MC-EOBA","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity","officialTitle":"A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTX3232 Alone or in Combination With Semaglutide in Participants With Obesity"},"statusModule":{"statusVerifiedDate":"2026-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2025-01-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-09-10","type":"ACTUAL"},"completionDateStruct":{"date":"2025-09-10","type":"ACTUAL"},"studyFirstSubmitDate":"2025-01-08","studyFirstSubmitQcDate":"2025-01-08","studyFirstPostDateStruct":{"date":"2025-01-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-09-09","resultsFirstSubmitQcDate":"2026-09-09","resultsFirstPostDateStruct":{"date":"2026-09-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-09-09","lastUpdatePostDateStruct":{"date":"2026-09-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Zomagen Biosciences Ltd.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study evaluated the safety of VTX3232 administered alone or in combination with semaglutide in participants with obesity. Approximately 160 participants were randomized to receive VTX3232 30 mg, placebo, VTX3232 30 mg in combination with semaglutide, or placebo in combination with semaglutide. The study consisted of a 30-day screening period, a 12-week double-blind treatment period, and a 30-day follow-up period. The maximum treatment duration was 12 weeks."},"conditionsModule":{"conditions":["Obesity"],"keywords":["NLRP3 Inhibitor","VTX3232","Zomagen"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"The study used a double-blind design for the study treatment tablets (VTX3232 or placebo). Assignment to treatment groups receiving semaglutide in combination with study treatment tablets or study treatment tablets alone was not blinded. Participants, investigators, study personnel, individuals performing assessments, and the sponsor remained blinded to the identity of the study treatment tablets until database lock.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":175,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose.","interventionNames":["Drug: Placebo"]},{"label":"VTX3232 30 mg","type":"EXPERIMENTAL","description":"Participants received VTX3232 30 milligrams (mg) orally once daily for 12 weeks and were followed for 30 days after the last dose.","interventionNames":["Drug: VTX3232 30 mg"]},{"label":"Placebo + Semaglutide","type":"ACTIVE_COMPARATOR","description":"Participants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.","interventionNames":["Drug: Placebo in combination with semaglutide"]},{"label":"VTX3232 30 mg + Semaglutide","type":"EXPERIMENTAL","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.","interventionNames":["Drug: VTX3232 30 mg in combination with semaglutide"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Placebo","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"VTX3232 30 mg","description":"VTX3232 30 mg","armGroupLabels":["VTX3232 30 mg"]},{"type":"DRUG","name":"Placebo in combination with semaglutide","description":"Placebo in combination with semaglutide","armGroupLabels":["Placebo + Semaglutide"]},{"type":"DRUG","name":"VTX3232 30 mg in combination with semaglutide","description":"VTX3232 30 mg in combination with semaglutide","armGroupLabels":["VTX3232 30 mg + Semaglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)","description":"A TEAE was defined as any adverse event that occurred after initiation of study treatment or any pre-existing adverse event that worsened in severity following initiation of study treatment.","timeFrame":"From the first dose of study treatment to Week 16"}],"secondaryOutcomes":[{"measure":"Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (Hs-CRP) Level","timeFrame":"From baseline to Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants are male or female ≥ 18 years up to ≤ 80 years of age.\n* Ability to comply with study requirements.\n* BMI ≥ 30.0 to ≤ 42.0 kg/m2 at screening.\n* Stable body weight (± 5%) for at least 3 months prior to screening.\n* hs-CRP ≥ 2 mg/L at screening.\n* Hypertension or hyperlipidemia which are known to be associated with increased risk of cardiovascular events, if present, must be controlled with stable dose/therapy.\n* History of at least one self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n* Obesity induced by endocrinologic disorders, or diagnosed genetic or syndromic forms of obesity\n* Have any prior diagnosis of diabetes mellitus\n* Current participation (or within the last 3 months) in an organized weight reduction program.\n* History or presence of clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility, have undergone prior surgical treatment for obesity (e.g., gastric bypass \\[bariatric\\] surgery or restrictive bariatric surgery), or have an endoscopic and/or device-based therapy for obesity.\n* Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.\n* Use of any medication (e.g., GLP-1 agonists), nutritional supplement, or over the counter product for weight loss within the previous 6 months or during study participation, unless administered as a part of assigned study treatment in this study.\n* Receipt of the following medications:\n\n  1. Any immunosuppressive biologic or targeted therapy within 90 days prior to Day 1.\n  2. Use of anti-inflammatory medications within 30 days prior to Day 1\n  3. Colchicine within 30 days prior to Day 1.\n  4. Glucose-lowering agent(s) administered for conditions other than diabetes within 90 days before screening.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Snehal Naik, PhD","affiliation":"Zomagen Biosciences Ltd.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"840005","city":"Birmingham","state":"Alabama","zip":"35235","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"840003","city":"Lake Forest","state":"California","zip":"92630","country":"United States","geoPoint":{"lat":33.64697,"lon":-117.68922}},{"facility":"840011","city":"Long Beach","state":"California","zip":"90815","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"840001","city":"Largo","state":"Florida","zip":"33761","country":"United States","geoPoint":{"lat":27.90979,"lon":-82.78842}},{"facility":"840012","city":"Ocoee","state":"Florida","zip":"34761","country":"United States","geoPoint":{"lat":28.56917,"lon":-81.54396}},{"facility":"840016","city":"Port Orange","state":"Florida","zip":"32127","country":"United States","geoPoint":{"lat":29.13832,"lon":-80.99561}},{"facility":"840014","city":"Newton","state":"Kansas","zip":"67114","country":"United States","geoPoint":{"lat":38.04668,"lon":-97.34504}},{"facility":"840015","city":"Marrero","state":"Louisiana","zip":"70072","country":"United States","geoPoint":{"lat":29.89937,"lon":-90.10035}},{"facility":"840017","city":"Marrero","state":"Louisiana","zip":"70072","country":"United States","geoPoint":{"lat":29.89937,"lon":-90.10035}},{"facility":"840002","city":"Austin","state":"Texas","zip":"78705","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"840006","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"840013","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"840018","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"840010","city":"Waco","state":"Texas","zip":"76710","country":"United States","geoPoint":{"lat":31.54933,"lon":-97.14667}}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"FG001","title":"VTX3232 30 mg","description":"Participants received VTX3232 30 milligrams (mg) orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"FG002","title":"Placebo + Semaglutide","description":"Participants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."},{"id":"FG003","title":"VTX3232 30 mg + Semaglutide","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"43"},{"groupId":"FG003","numSubjects":"45"}]},{"type":"Received at Least One Dose of the Study Drug","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"43"},{"groupId":"FG003","numSubjects":"45"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"40"},{"groupId":"FG003","numSubjects":"38"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least one dose of the study drug.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"BG001","title":"VTX3232 30 mg","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"BG002","title":"Placebo + Semaglutide","description":"Participants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."},{"id":"BG003","title":"VTX3232 30 mg + Semaglutide","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"45"},{"groupId":"BG004","value":"175"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.0","spread":"13.49"},{"groupId":"BG001","value":"45.9","spread":"13.45"},{"groupId":"BG002","value":"47.7","spread":"13.44"},{"groupId":"BG003","value":"49.7","spread":"14.67"},{"groupId":"BG004","value":"47.6","spread":"13.74"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"35"},{"groupId":"BG004","value":"136"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"39"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"45"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"30"},{"groupId":"BG004","value":"130"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"4"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"3"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"48"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"119"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"45"},{"groupId":"BG004","value":"175"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)","description":"A TEAE was defined as any adverse event that occurred after initiation of study treatment or any pre-existing adverse event that worsened in severity following initiation of study treatment.","populationDescription":"All randomized participants who received at least one dose of the study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"From the first dose of study treatment to Week 16","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"OG001","title":"VTX3232 30 mg","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"OG002","title":"Placebo + Semaglutide","description":"Participants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."},{"id":"OG003","title":"VTX3232 30 mg + Semaglutide","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"45"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"25"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (Hs-CRP) Level","populationDescription":"All randomized participants who received at least one dose of the study drug and had evaluable baseline and Week 12 assessments for this outcome.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Percent change","timeFrame":"From baseline to Week 12","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"OG001","title":"VTX3232 30 mg","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and were followed for 30 days after the last dose."},{"id":"OG002","title":"Placebo + Semaglutide","description":"Participants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."},{"id":"OG003","title":"VTX3232 30 mg + Semaglutide","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.98","lowerLimit":"-30.56","upperLimit":"40.82"},{"groupId":"OG001","value":"-63.77","lowerLimit":"-83.45","upperLimit":"-20.00"},{"groupId":"OG002","value":"-28.11","lowerLimit":"-48.28","upperLimit":"3.13"},{"groupId":"OG003","value":"-75.00","lowerLimit":"-91.67","upperLimit":"-25.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Hodges-Lehmann estimate","paramValue":"-56.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-80.77","ciUpperLimit":"-34.24"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0128","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Hodges-Lehmann estimate","paramValue":"-24.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-48.41","ciUpperLimit":"-6.23"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Hodges-Lehmann estimate","paramValue":"-65.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-86.41","ciUpperLimit":"-47.59"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Hodges-Lehmann estimate","paramValue":"-41.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-57.93","ciUpperLimit":"-23.33"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline to Week 16","description":"All randomized participants who received at least one dose of the study drug.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose.","deathsNumAffected":0,"deathsNumAtRisk":43,"seriousNumAffected":0,"seriousNumAtRisk":43,"otherNumAffected":13,"otherNumAtRisk":43},{"id":"EG001","title":"VTX3232 30 mg","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and were followed for 30 days after the last dose.","deathsNumAffected":0,"deathsNumAtRisk":44,"seriousNumAffected":1,"seriousNumAtRisk":44,"otherNumAffected":10,"otherNumAtRisk":44},{"id":"EG002","title":"Placebo + Semaglutide","description":"Participants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.","deathsNumAffected":0,"deathsNumAtRisk":43,"seriousNumAffected":0,"seriousNumAtRisk":43,"otherNumAffected":20,"otherNumAtRisk":43},{"id":"EG003","title":"VTX3232 30 mg + Semaglutide","description":"Participants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.","deathsNumAffected":0,"deathsNumAtRisk":45,"seriousNumAffected":0,"seriousNumAtRisk":45,"otherNumAffected":22,"otherNumAtRisk":45}],"seriousEvents":[{"term":"Major depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":43},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":44},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":43},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":45}]}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":43},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":43},{"groupId":"EG003","numEvents":7,"numAffected":6,"numAtRisk":45}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":43},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44},{"groupId":"EG002","numEvents":5,"numAffected":3,"numAtRisk":43},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":45}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":43},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":44},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":43},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":45}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":43},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44},{"groupId":"EG002","numEvents":9,"numAffected":8,"numAtRisk":43},{"groupId":"EG003","numEvents":12,"numAffected":10,"numAtRisk":45}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":43},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":44},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":43},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":45}]},{"term":"Early satiety","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":43},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":43},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":45}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":43},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":44},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":43},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":45}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":43},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":44},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":43},{"groupId":"EG003","numEvents":6,"numAffected":6,"numAtRisk":45}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":43},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":43},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":45}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2025-03-14","uploadDate":"2026-09-02T22:01","filename":"Prot_000.pdf","size":3051534},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2025-09-25","uploadDate":"2026-09-02T22:02","filename":"SAP_001.pdf","size":2857480}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"}],"ancestors":[{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"C000591245","term":"semaglutide"}]}},"hasResults":true}