Semaglutide 2.4mg for Low Responders After Bariatric Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZuyderland Medisch Centrum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI before surgery was ≥ 35.0 kg/m2
Patient is treated with group consultation at the NOK
Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG)
Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.
Disqualifiers
Gastropareses or gastro-intestinal complaints after bariatric surgery
Type 1 or type 2 diabetes and/or diabetic retinopathy
Decreased renal function (creatinine clearance < 30 ml/min)
Liver failure (all)
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Other interventionThe placebo will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.
Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]
DrugThe semaglutide will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Semaglutide 2.4mgActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight change from start study at 3 months post operative until 15 months later
To study the weight change from 3 until 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
Time frame
15 months2
Difference between placebo group and treatment group in weight change
compare change in weight to patients receiving placebo and a lifestyle intervention
Time frame
15 monthsSecondary outcomes
1
Weight loss 3 months after surgery
To study the weight loss at 3 months after surgery (before semaglutide start)
Time frame
3 months2
Weight loss 6 months after surgery
To study the weight loss at 6 months after surgery (3 months after semaglutide start)
Time frame
6 months3
Weight loss 12 months after surgery
To study the weight loss at 12 months after surgery (9 months after semaglutide start)
Time frame
12 months4
Weight loss 18 months after surgery
To study the weight loss at18 months after surgery (15 months after semaglutide start)
Time frame
18 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zuyderland Medisch Centrum
Lead sponsor
Nederlandse Obesitas Kliniek
Collaborator
Source ClinicalTrials.gov
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