{"protocolSection":{"identificationModule":{"nctId":"NCT03048578","orgStudyIdInfo":{"id":"16-01527"},"organization":{"fullName":"NYU Langone Health","class":"OTHER"},"briefTitle":"Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery","officialTitle":"Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery"},"statusModule":{"statusVerifiedDate":"2022-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-05-22","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-03-02","type":"ACTUAL"},"completionDateStruct":{"date":"2021-03-02","type":"ACTUAL"},"studyFirstSubmitDate":"2017-02-07","studyFirstSubmitQcDate":"2017-02-07","studyFirstPostDateStruct":{"date":"2017-02-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-02-24","resultsFirstSubmitQcDate":"2022-02-24","resultsFirstPostDateStruct":{"date":"2022-03-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-12-06","lastUpdatePostDateStruct":{"date":"2022-12-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"NYU Langone Health","class":"OTHER"},"collaborators":[{"name":"Novo Nordisk A/S","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.","detailedDescription":"The specific aims of this study are to:\n\n* To evaluate the effects of liraglutide on body weight loss in patients who are experiencing weight regain following RYGB.\n* To evaluate the effects of liraglutide on cardiometabolic risk and quality of life in patients who are experiencing weight regain following RYGB.\n* To evaluate the safety of liraglutide in post-RYGB subjects.\n* To evaluate the changes in obesity-related comorbid conditions in patients who are experiencing weight regain following RYGB."},"conditionsModule":{"conditions":["Obesity"],"keywords":["Roux-en-Y gastric bypass (RYGB)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Randomization will be 2:1 (drug:placebo) with stratification by gender and percent post-operative TBWL (25%, 25 - 49.9%).","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","CARE_PROVIDER"]}},"enrollmentInfo":{"count":132,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Saxenda","type":"EXPERIMENTAL","description":"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day","interventionNames":["Drug: Saxenda"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Saxenda","description":"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day","armGroupLabels":["Saxenda"],"otherNames":["Victoza"]},{"type":"DRUG","name":"Placebo","description":"Subcutaneous Saline Solution","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test","description":"CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification","timeFrame":"12 Months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* ≥18 months status-post RYGB\n* BMI 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition\n* BMI 30 kg/m2 or greater\n* Regain of ≥10% of maximum TBWL post-RYGB\n* Ability to provide informed consent before any trial-related activities\n* Express willingness to follow protocol requirements\n\nExclusion Criteria:\n\n* Pregnancy at time of enrollment\n* Intention of becoming pregnant or breast feeding in the next 12 months\n* Females of childbearing potential who are not using adequate contraceptive methods\n* Presence of acute psychiatric problems or immaturity which would compromise cooperation with the study protocol\n* Presence of biliary disease\n* Known or suspected allergy to liraglutide or any product components\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n* History of pancreatitis\n* History of alcoholism\n* History of Type 1 DM (Diabetes Mellitus)\n* History of previous bariatric surgery other than RYGB except h/o LAGB and band removal.\n* \\>10 years status-post RYGB\n* \\< 25% TBWL at post-RYGB weight nadir\n* \\>50% post-operative TBWL at time of screening\n* Simultaneous use of any weight loss medications\n* Use of insulin at the time of enrollment\n* Current use of any GLP-1 agonist medication\n* History of taking any GLP-1 agonist medication\n* Participation in another ongoing clinical study\n* Conditions that, in the opinion of the principal investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 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