Bupropion hydrochloride; Naltrexone hydrochloride for Obesity|Weight regain after bariatric surgery

Inclusion criteria

• {"criterion_text":"- Patient is ≥18 and <75 years old"}
• {"criterion_text":"- BMI before surgery was ≥ 35.0 kg/m2"}
• {"criterion_text":"- Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)"}
• {"criterion_text":"- 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: •\tPatient is ≥18 and <75 years old •\tPatient is obese (BMI > 30 kg/m2) •\tPatient on successful Mysimba steady maintenance dose"}

Exclusion criteria

• {"criterion_text":"- Anatomical or surgical abnormalities for which revisional surgery is indicated."}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Patients suffering from: o\tunregulated hypertension o\ta tumour in the central nervous system o\tsevere liver failure o\tend stage kidney failure"}
• {"criterion_text":"- Patients suffering from or with a history of insults"}
• {"criterion_text":"- Patients with a history of: o\tbipolar disease o\tbulimia or anorexia nervosa"}
• {"criterion_text":"- Patients withdrawing from alcohol or benzodiazepines"}
• {"criterion_text":"- Patients with excessive use of alcohol or drugs"}
• {"criterion_text":"- Patients who are not able to understand the informed consent form and patient information."}

Primary endpoints

• {"endpoint_text":"- The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss (>5% weight loss) after 22 weeks compared with the regular BOT module alone, in patients with weight regain after bariatric surgery. Assessment of bodyweight is standard part of treatment.","definition_or_measurement_approach":"Successful weight loss defined as >5% weight loss at 22 weeks; assessment by bodyweight measurement (\"Assessment of bodyweight is standard part of treatment\"), comparing naltrexone/bupropion + BOT module versus regular BOT module alone."}

Netherlands

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

17-01-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

157

Primary sponsor

Full Name

Zuyderland Medisch Centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands