SEMAGLUTIDE for Obesity

Inclusion criteria

• {"criterion_text":"- Patient is ≥18 and <75 years old\n- BMI before surgery was ≥ 35.0 kg/m2\n- Patient is treated with group consultation at the Dutch Obesity Clinic (DOC)\n- Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG)\n- Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module."}

Exclusion criteria

• {"criterion_text":"- Type 1 or type 2 diabetes\n- Use of warfarin or other coumarin derivates\n- Decreased renal function (creatinine clearance < 30 ml/min)\n- Liver failure (all)\n- Congestive heart failure or angina pectoris NYHA class III and IV\n- Malignancy in history\n- Pancreatitis (in history)\n- Pregnancy / breast-feeding\n- Inflammatory Bowel Disease\n- Thyroid malignancy in history"}

Primary endpoints

• {"endpoint_text":"- The main endpoint is change in %TWL from 3 to 18 months after bariatric surgery (15 months/ 68 weeks after semaglutide start). Assessment of bodyweight is standard part of treatment.","definition_or_measurement_approach":"Change in % total weight loss (%TWL) from 3 to 18 months after surgery; bodyweight assessment is standard part of treatment."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoints are %TWL at 3, 6, 12 and 18 months, metabolic health, quality of life and gastro-intestinal symptoms, cardiorespiratory fitness, liver fat and liver stiffness, and persistence of therapy (see attachment 1).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Body weight and BMI will be measured before surgery and 3, 6, 12 and 18 months after surgery. %TWL at 3, 6, 12 and 18 months after surgery will be calculated using the weight at start of treatment. Furthermore, waist circumference and waist/hip ratio will be measured at start of the treatment and at all follow up moments.","definition_or_measurement_approach":"Body weight and BMI measured at specified timepoints; %TWL calculated using weight at start of treatment; waist circumference and waist/hip ratio measured at start and follow-up visits."}
• {"endpoint_text":"- Metabolic health will be defined by using the following parameters: blood pressure, HbA1c, glucose, triglycerides and LDL, HDL and total cholesterol. Hypertension and dyslipidemia will be recorded at all follow-up moments to assess whether there is improvement or remission of comorbid conditions in patients who have those comorbid conditions.","definition_or_measurement_approach":"Metabolic health assessed via blood pressure, HbA1c, glucose, triglycerides, LDL, HDL and total cholesterol; recording of hypertension and dyslipidemia at all follow-ups."}
• {"endpoint_text":"- Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the “eating habits and physical problems” scales of the BODY-Q questionnaire. This same questionnaire will also be used to study HRQoL (see attachment 2). Before surgery and at 3 (start of study), 6, 12 and 18 months the HRQoL and gastro-intestinal symptoms will be assessed.","definition_or_measurement_approach":"Assessment via adverse event reporting and BODY-Q questionnaire scales at specified timepoints for HRQoL and gastrointestinal symptoms."}
• {"endpoint_text":"- Cardiorespiratory Fitness will be assessed before surgery, and at 3 (start of study), 6, 12 and 18 months after surgery. During the Åstrand test, participants cycle for 6 min on a cycle ergometer on submaximal level. After the test, VO2max is calculated by combining the patient’s characteristics (age, sex, weight, and fat-free mass (FFM)) with outcomes of the Åstrand test (level of resistance and heart rate).","definition_or_measurement_approach":"Åstrand submaximal cycle test; VO2max calculated from patient characteristics and test outcomes (resistance level and heart rate)."}
• {"endpoint_text":"- Liver fat and liver stiffness will be assessed at the start of the study and after using semaglutide for 68 weeks. Using vibration controlled transient elastography this parameter will be assessed. Vibration controlled transient elastography (VCTE) is a diagnostically accurate method to assess liver fat and liver stiffness. All values will be expressed in kPa.","definition_or_measurement_approach":"Measured by vibration controlled transient elastography (VCTE); results expressed in kPa."}
• {"endpoint_text":"- For this we will assess: -\tNumber and percentage of patients in whom dose escalation was according to protocol -\tNumber and percentage of patients who used 2.4 mg as a weekly dose for 52 weeks -\tAverage weekly dose of all patients (after the dose escalation)","definition_or_measurement_approach":"Assessment of protocol adherence for dose escalation, proportion using 2.4 mg weekly for 52 weeks, and average weekly dose after escalation."}

Netherlands

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

06-03-2025

Processing Time Days

184

Number Of Sites

3

Number Of Participants

152

Primary sponsor

Full Name

Stichting Zuyderland Medisch Centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands