nctId: NCT06287307 id: NOK000024 briefTitle: Semaglutide 2.4mg for Low Responders After Bariatric Surgery acronym: SEABAR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-02 date: 2026-09 date: 2024-03-01 date: 2024-03-01 name: Zuyderland Medisch Centrum class: OTHER name: Nederlandse Obestias Kliniek (NOK) 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. conditions: Obesity conditions: Obesity, Morbid conditions: Weight Gain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 152 type: ESTIMATED name: Placebo name: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] measure: Weight change from start study at 3 months post operative until 15 months later measure: Difference between placebo group and treatment group in weight change measure: Weight loss 3 months after surgery measure: Weight loss 6 months after surgery measure: Weight loss 12 months after surgery measure: Weight loss 18 months after surgery measure: Metabolic health before surgery (bloodpressure) measure: Metabolic health before surgery (HbA1c) measure: Metabolic health before surgery (glucose) measure: Metabolic health before surgery (triglyceride) measure: Metabolic health before surgery (LDL) measure: Metabolic health before surgery (HDL) measure: Metabolic health before surgery (total cholesterol) measure: Metabolic health 3 months after surgery (Bloodpressure) measure: Metabolic health 3 months after surgery (HbA1c) measure: Metabolic health 3 months after surgery (glucose) measure: Metabolic health 3 months after surgery (triglyceride) measure: Metabolic health 3 months after surgery (LDL) measure: Metabolic health 3 months after surgery (HDL) measure: Metabolic health 3 months after surgery (total cholesterol) measure: Metabolic health at 6 months after surgery (bloodpressure) measure: Metabolic health at 6 months after surgery (HbA1c) measure: Metabolic health at 6 months after surgery (glucose) measure: Metabolic health at 6 months after surgery (triglyceride) measure: Metabolic health at 6 months after surgery (LDL) measure: Metabolic health at 6 months after surgery (HDL) measure: Metabolic health at 6 months after surgery (total cholesterol) measure: Metabolic health at 12 months after surgery (bloodpressure) measure: Metabolic health at 12 months after surgery (HbA1c) measure: Metabolic health at 12 months after surgery (glucose) measure: Metabolic health at 12 months after surgery (triglyceride) measure: Metabolic health at 12 months after surgery (LDL) measure: Metabolic health at 12 months after surgery (HDL) measure: Metabolic health at 12 months after surgery (total cholesterol) measure: Metabolic health at 18 months after surgery (bloodpressure) measure: Metabolic health at 18 months after surgery (HbA1c) measure: Metabolic health at 18 months after surgery (glucose) measure: Metabolic health at 18 months after surgery (triglyceride) measure: Metabolic health at 18 months after surgery (LDL) measure: Metabolic health at 18 months after surgery (HDL) measure: Metabolic health at 18 months after surgery (total cholesterol) measure: Health-related quality of life also related to gastro intestinal symptoms before surgery measure: Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery measure: Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery measure: Health-related quality of life also related to gastro intestinal symptoms measure: Health-related quality of life also related to gastro intestinal symptoms measure: Cardiorespiratory fitness level before surgery measure: Cardiorespiratory fitness level 3 months after surgery measure: Cardiorespiratory fitness level 6 months after surgery measure: Cardiorespiratory fitness level 12 months after surgery measure: Cardiorespiratory fitness level 18 months after surgery measure: Change in liver fat and liver stiffness at start of treatment measure: Change in liver fat and liver stiffness 15 months after semaglutide start measure: To describe the persistence of therapy measure: To describe the average weekly dose sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False