SYF578f289ee53a496896dde51b22007c23Registry ID: 2022-502164-20-01|RecruitingPhase 4
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Secondary identifiers
interventional
N/A
1 country
3
To study the weight change from 3 to 18 months after surgery (% total weight loss, TWL) in low responders after bariatric surgery who are treated with Semaglutide 2.4 mg and a lifestyle intervention and compare change in weight to patients receiving placebo and a lifestyle intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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November 15, 2023
Actual (reported)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.
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).
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.
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.
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.
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).
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Formulated product
Semaglutide B 3.0 mg/ml PDS290
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SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Semaglutide B 3.0 mg/ml PDS290
Named ingredient: Semaglutide
View registry recordZuyderland Medisch Centrum Stichting
Heerlen, 6419 PC, Netherlands
Rode Kruis Ziekenhuis B.V.
Beverwijk, 1942 LE, Netherlands
Sint Antonius Ziekenhuis Stichting
Nieuwegein, 3435 CM, Netherlands
Bureau Wetenschappelijk Onderzoek
First Submitted
November 15, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Mirabegron and Brown Adipose Tissue
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