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

Qualifiers

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

Treatments tested in this trial

  • Placebo
  • Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]

Treatment groups

152 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Zuyderland Medisch Centrum

Lead sponsor

Nederlandse Obesitas Kliniek

Collaborator