Use of Mysimba in Patients With Weight Regain After Bariatric Surgery
1 other identifier
interventional
116
1 country
1
Brief Summary
Although bariatric surgery is currently the most effective treatment for morbid obesity, weight regain occurs in 16-37% of the patients (1). Weight regain is not regularly treated with antiobesity medications (AOMs). Mysimba (Contrave in US) is a AOM, it is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Bupropion is a mild reuptake inhibitor of dopamine and norepinephrine. Naltrexone, an opioid antagonist has minimum effect on weight loss on its own. Naltrexone is thought to block the inhibitory effects of opioid receptors activated by the β-endorphin released in the hypothalamus that stimulates feeding, thus allowing the inhibitory effects of α-melanocyte stimulating hormone to reduce food intake. In patients with obesity usage of Naltrexone/Bupropion (NB) results in up to 8.2% weight loss (2). There is some evidence that also in bariatric patients with weight regain NB leads to additional weight loss (3, 4). At the Nederlandse Obesitas Kliniek (NOK) weight regain at follow-up is currently treated with the Back on Track (BOT) program. The BOT program is an extra intervention our clinic provides for the patients who have weight regain after surgery, this is part of our standard care program. 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 in patients with weight regain after bariatric surgery, compared to the regular BOT module.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMay 30, 2023
July 1, 2022
1.9 years
May 18, 2021
May 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect naltrexone-bupropion in combination with the BOT module
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.
22 weeks
Secondary Outcomes (8)
Persistence
22 weeks
Tolerated dosage
22 weeks
Adverse effects
22 weeks
Weight loss
12 months
Eating habits
22 weeks
- +3 more secondary outcomes
Study Arms (2)
Naltrexone-Bupropion combination
ACTIVE COMPARATORThe patients in this arm will receive 2 tablets of naltrexone-bupropion 8/90mg 2 times daily in combination with the Back On Track module.
Control
NO INTERVENTIONThe patients is this arm will only participate in the Back On Track module and will not receive any investigational or placebo product.
Interventions
Naltrexone-bupropion will be added to the BOT module in the interventional arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Anatomical or surgical abnormalities for which revisional surgery is indicated.
- Use of the following medication Monoamino-oxidase inbibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
- Pregnancy or breastfeeding
- Patients suffering from:
- unregulated hypertension
- a tumour in the central nervous system
- severe liver failure
- end stage kidney failure
- Patients suffering from or with a history of insults
- Patients with a history of:
- bipolar disease
- bulimia or anorexia nervosa
- Patients withdrawing from alcohol or benzodiazepines
- Patients who are not able to understand the informed consent form and patient information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zuyderland Medisch Centrumlead
- Nederlandse Obesitas Kliniekcollaborator
Study Sites (1)
Zuyderland Medical Center
Heerlen, Limburg, 6419 PC, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Willem Greve, MD, PhD, professor
Nederlandse Obesitas Kliniek Zuid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
May 26, 2021
Study Start
March 21, 2023
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
May 30, 2023
Record last verified: 2022-07