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Applying Mysimba in patients with weight regain after bariatric surgery
EU CTIS ID: 2024-516645-39-01
What this study is testing
Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgery
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient is ≥18 and <75 years old
- BMI before surgery was ≥ 35.0 kg/m2
- Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
- Gaining more than 5% weight after reaching plateau phase of lowest weight To be eligible to participate in the control patient cohort for measuring bupropion and hydroxybupropion serum levels a subject must meet all of the following criteria: • Patient is ≥18 and <75 years old • Patient is obese (BMI > 30 kg/m2) • Patient on successful Mysimba steady maintenance dose
You likely can't join if
- Anatomical or surgical abnormalities for which revisional surgery is indicated.
- Use of the following medication Monoamino-oxidase inhibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
- Pregnancy or breastfeeding
- Patients suffering from: o unregulated hypertension o a tumour in the central nervous system o severe liver failure o end stage kidney failure
- Patients suffering from or with a history of insults
- Patients with a history of: o bipolar disease o bulimia or anorexia nervosa
See the full eligibility criteria
- Patient is ≥18 and <75 years old
- BMI before surgery was ≥ 35.0 kg/m2
- Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
- Gaining more than 5% weight after reaching plateau phase of lowest weight To be eligible to participate in the control patient cohort for measuring bupropion and hydroxybupropion serum levels a subject must meet all of the following criteria: • Patient is ≥18 and <75 years old • Patient is obese (BMI > 30 kg/m2) • Patient on successful Mysimba steady maintenance dose
- Anatomical or surgical abnormalities for which revisional surgery is indicated.
- Use of the following medication Monoamino-oxidase inhibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
- Pregnancy or breastfeeding
- Patients suffering from: o unregulated hypertension o a tumour in the central nervous system o severe liver failure o end stage kidney failure
- Patients suffering from or with a history of insults
- Patients with a history of: o bipolar disease o bulimia or anorexia nervosa
- Patients withdrawing from alcohol or benzodiazepines
- Patients with excessive use of alcohol or drugs
- Patients who are not able to understand the informed consent form and patient information.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.