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Study on Bupropion Hydrochloride and Naltrexone Hydrochloride for Patients with Weight Regain After Bariatric Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have experienced weight regain after undergoing Obesity Surgery, specifically procedures like Roux-en-Y gastric bypass or Gastric Sleeve surgery. The study is investigating the effects of a medication called Mysimba, which is a combination of two active substances: Bupropion Hydrochloride and Naltrexone Hydrochloride. These substances are used in the form of prolonged-release tablets, which means they release the medication slowly over time.

The purpose of the study is to understand how effective Mysimba is in helping patients lose weight after they have regained it following their surgery. The study will compare the weight loss results of patients taking Mysimba with those who are not, over a period of 22 weeks. The goal is to see if patients taking Mysimba can achieve a weight loss of more than 5% compared to those who do not take the medication.

Participants in the study will take the medication orally, and their progress will be monitored to assess the impact of the treatment. The study aims to provide insights into the dose response of Mysimba in patients who have had weight loss surgery and are experiencing weight regain. This research could help improve treatment options for individuals struggling with Obesity after surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Introduction to the trial
The trial focuses on the use of Mysimba in patients who have experienced weight regain after bariatric surgery. The main goal is to evaluate the dose response of Mysimba following Roux-en-Y gastric bypass or gastric sleeve surgery.
Step 2
Eligibility confirmation
Eligibility criteria include being between 18 and 75 years old, having a body mass index (BMI) of 35 kg/m² or more before surgery, and having undergone a primary banded or non-banded Roux-en-Y gastric bypass or sleeve gastrectomy. Additionally, participants must have gained more than 5% of their weight after reaching the lowest weight plateau.
Step 3
Medication administration
Participants will receive Mysimba 8 mg/90 mg prolonged-release tablets. The medication is taken orally. The specific dosage and frequency will be determined based on individual response and the study protocol.
Step 4
Treatment duration
The treatment period is set for 22 weeks. During this time, the effect of the combination of naltrexone and bupropion, which are the active substances in Mysimba, will be assessed in conjunction with the BOT module.
Step 5
Primary objective assessment
The primary objective is to evaluate the effectiveness of the treatment in achieving more than 5% weight loss compared to the regular BOT module alone. Bodyweight assessment is a standard part of the treatment process.
Step 6
Trial completion
The estimated end date for the trial is April 1, 2026. Participants will be monitored throughout the trial to ensure safety and effectiveness of the treatment.

Who can join the trial?

7 criteria

Patient must be at least 18 years old and younger than 75 years old.
Before surgery, the patient's BMI (Body Mass Index) must have been 35.0 kg/m² or higher. BMI is a number calculated from a person's weight and height.
Patient must have had a primary Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery. These are types of weight-loss surgeries.
Patient must have gained more than 5% of their weight after reaching the lowest weight following surgery.
To be part of the control group for measuring certain medication levels, the patient must be at least 18 years old and younger than 75 years old.
Patient must be considered obese, with a BMI greater than 30 kg/m².
Patient must be on a successful steady maintenance dose of Mysimba, a medication used for weight management.

Who cannot join the trial?

3 criteria

Patients who have not undergone **Roux-en-Y gastric bypass** or **Gastric Sleeve surgery**. These are types of weight-loss surgeries.
Patients who are not within the specified age range for the study. The study includes certain age groups, so if you are outside these groups, you cannot participate.
Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.

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Verified sites

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Zuyderland Medisch Centrum Stichting
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Geleen, The Netherlands

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Investigated drugs

Mysimba is a medication used to help manage weight in patients who have experienced weight regain after undergoing bariatric surgery, such as Roux-en-Y gastric bypass or gastric sleeve surgery. It works by affecting certain areas of the brain that control appetite and energy balance, helping patients to reduce their food intake and increase their energy expenditure.

What is already known about the treatment

Mysimba – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in managing weight regain after bariatric surgery, specifically Roux-en-Y gastric bypass or gastric sleeve surgery. Mysimba is primarily indicated for the treatment of obesity. It works by affecting the central nervous system to reduce appetite and increase energy expenditure. Mysimba is classified as an anti-obesity agent.

Investigated diseases

Obesity
Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. The condition develops gradually over time, often due to a combination of genetic, behavioral, and environmental factors. Obesity can lead to various health issues, including heart disease, diabetes, and joint problems. It often requires lifestyle changes to manage effectively.
Obesity Surgery
Obesity surgery, also known as bariatric surgery, is a medical procedure aimed at aiding weight loss in individuals with severe obesity. This surgery alters the digestive system to limit food intake or nutrient absorption. Common types include Roux-en-Y gastric bypass and gastric sleeve surgery. The procedure is typically considered when other weight loss methods have not been successful. It can lead to significant weight loss and improvement in obesity-related conditions. The surgery requires a commitment to long-term lifestyle changes for optimal results.