Clinical trial

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Opening soon · Phase 4 · 0 countries · Registry ID NCT06287307

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Obesity, Morbid, Weight Gain

Full registry 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

Treatments and study arms

Placebo

Other

The 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]

Drug

The semaglutide will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.

Primary outcomes

Weight change from start study at 3 months post operative until 15 months later15 months

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

Difference between placebo group and treatment group in weight change15 months

compare change in weight to patients receiving placebo and a lifestyle intervention

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.