protocolSection identificationModule nctId: NCT06287307, orgStudyIdInfo id: NOK000024, briefTitle: Semaglutide 2.4mg for Low Responders After Bariatric Surgery, acronym: SEABAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Zuyderland Medisch Centrum, class: OTHER, collaborators name: Nederlandse Obestias Kliniek (NOK), descriptionModule briefSummary: In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight., conditionsModule conditions: Obesity, conditions: Obesity, Morbid, conditions: Weight Gain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY], outcomesModule primaryOutcomes measure: Weight change from start study at 3 months post operative until 15 months later, primaryOutcomes measure: Difference between placebo group and treatment group in weight change, secondaryOutcomes measure: Weight loss 3 months after surgery, secondaryOutcomes measure: Weight loss 6 months after surgery, secondaryOutcomes measure: Weight loss 12 months after surgery, secondaryOutcomes measure: Weight loss 18 months after surgery, secondaryOutcomes measure: Metabolic health before surgery (bloodpressure), secondaryOutcomes measure: Metabolic health before surgery (HbA1c), secondaryOutcomes measure: Metabolic health before surgery (glucose), secondaryOutcomes measure: Metabolic health before surgery (triglyceride), secondaryOutcomes measure: Metabolic health before surgery (LDL), secondaryOutcomes measure: Metabolic health before surgery (HDL), secondaryOutcomes measure: Metabolic health before surgery (total cholesterol), secondaryOutcomes measure: Metabolic health 3 months after surgery (Bloodpressure), secondaryOutcomes measure: Metabolic health 3 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health 3 months after surgery (glucose), secondaryOutcomes measure: Metabolic health 3 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health 3 months after surgery (LDL), secondaryOutcomes measure: Metabolic health 3 months after surgery (HDL), secondaryOutcomes measure: Metabolic health 3 months after surgery (total cholesterol), secondaryOutcomes measure: Metabolic health at 6 months after surgery (bloodpressure), secondaryOutcomes measure: Metabolic health at 6 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health at 6 months after surgery (glucose), secondaryOutcomes measure: Metabolic health at 6 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health at 6 months after surgery (LDL), secondaryOutcomes measure: Metabolic health at 6 months after surgery (HDL), secondaryOutcomes measure: Metabolic health at 6 months after surgery (total cholesterol), secondaryOutcomes measure: Metabolic health at 12 months after surgery (bloodpressure), secondaryOutcomes measure: Metabolic health at 12 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health at 12 months after surgery (glucose), secondaryOutcomes measure: Metabolic health at 12 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health at 12 months after surgery (LDL), secondaryOutcomes measure: Metabolic health at 12 months after surgery (HDL), secondaryOutcomes measure: Metabolic health at 12 months after surgery (total cholesterol), secondaryOutcomes measure: Metabolic health at 18 months after surgery (bloodpressure), secondaryOutcomes measure: Metabolic health at 18 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health at 18 months after surgery (glucose), secondaryOutcomes measure: Metabolic health at 18 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health at 18 months after surgery (LDL), secondaryOutcomes measure: Metabolic health at 18 months after surgery (HDL), secondaryOutcomes measure: Metabolic health at 18 months after surgery (total cholesterol), secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms before surgery, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms, secondaryOutcomes measure: Cardiorespiratory fitness level before surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 3 months after surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 6 months after surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 12 months after surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 18 months after surgery, secondaryOutcomes measure: Change in liver fat and liver stiffness at start of treatment, secondaryOutcomes measure: Change in liver fat and liver stiffness 15 months after semaglutide start, secondaryOutcomes measure: To describe the persistence of therapy, secondaryOutcomes measure: To describe the average weekly dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False