Clinical trial

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Name
NOK000024
Description
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.
Trial arms
Trial start
2024-05-01
Estimated PCD
2026-02-01
Trial end
2026-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Placebo
The placebo will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.
Arms:
Placebo
Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]
The semaglutide will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.
Arms:
Semaglutide 2.4mg
Other names:
Wegovy, Semaglutide
Size
152
Primary endpoint
Weight change from start study at 3 months post operative until 15 months later
15 months
Difference between placebo group and treatment group in weight change
15 months
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * Congestive heart failure or angina pectoris NYHA class III and IV * Malignancy in history * Pancreatitis (in history) * (expected) Pregnancy / breast-feeding * Inflammatory Bowel Disease * Thyroid malignancy in history * Use of warfarin or other coumarin derivates
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 152, 'type': 'ESTIMATED'}}
Updated at
2024-03-01

1 organization

1 product

3 indications

Indication
Obesity
Indication
Morbid
Indication
Weight Gain