AuthorisedPhase III and phase IV (Integrated)Interventional

Applying Mysimba in patients with weight regain after bariatric surgery

This research study is for people in the UK who have had weight-loss surgery (bariatric surgery) but have since put some weight back on. The main aim is to see if a specific medication, called Mysimba, can help them lose that weight again. Participants will either receive Mysimba along with standard lifestyle advice, or just the standard lifestyle advice by itself. Researchers will measure if those receiving Mysimba achieve at least 5% weight loss over 22 weeks compared to the other group. This study hopes to find new ways to support individuals who experience weight regain after bariatric surgery, helping them get back on track with their weight loss journey.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Zuyderland Medisch Centrum Stichting

Enrolment target

157

Start

17 Jan 2025

Obesity Obesity Surgery

What is this study about?

This study is looking into a common challenge faced by some people who have had weight-loss surgery, also known as bariatric surgery. While this surgery is very effective for many, some individuals might find that they gradually start to regain some weight over time. This can be frustrating and difficult to manage on your own.

Researchers want to find out if a medication called Mysimba, when used alongside the usual advice and support for healthy living (often called a Behavioural Optimisation Treatment, or BOT module), can help people in this situation. They will compare this approach to just receiving the standard healthy living advice by itself. The main goal is to see if taking Mysimba helps people lose at least 5% of their body weight over approximately 22 weeks.

Understanding how to best support people who experience weight regain after bariatric surgery is really important. This study aims to provide more evidence on whether Mysimba could be a useful tool to help people achieve further weight loss and maintain their health journey after their initial surgery. Your participation could help improve future care for others facing similar challenges.

Key takeaways

This study explores a medication called Mysimba for weight regain after bariatric surgery.
It aims to see if Mysimba, plus lifestyle advice, helps achieve at least 5% weight loss.
Participation involves about 22 weeks of assessment and monitoring.
You might receive Mysimba or just lifestyle advice – it's decided randomly.
Both men and women, aged 18 and over, who have had weight-loss surgery and regained weight, may be eligible.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part.

To be eligible, you must have previously had weight-loss surgery and then experienced some weight regain. The study will carefully check other health details to make sure it's safe for you to take part and that the results will be meaningful.

It's important to discuss with your doctor if this study might be suitable for you, as there will be specific medical criteria you need to meet.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had bariatric (weight-loss) surgery in the past?
Have you regained some weight since your bariatric surgery?
Are you able to commit to about 22 weeks for the study?
Are you happy for your treatment to be decided by chance (Mysimba or lifestyle advice)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for about 22 weeks. You'll either receive the study medication, Mysimba, along with your usual healthy lifestyle advice, or you'll just receive the healthy lifestyle advice alone. This decision is made randomly, like flipping a coin.

Throughout the study, you'll have regular visits to monitor your health and weight. These visits are a standard part of managing your weight and will help the research team understand how well the different approaches are working. You'll receive the study medication (Mysimba prolonged-release tablets) to take as prescribed, or you'll follow a programme of healthy lifestyle advice. The research team will guide you through all the steps and appointments required.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new medication that might help with weight loss, along with regular medical monitoring and support. However, there are also potential risks, as with any medication, which will be fully explained to you by the study team. These might include side effects, although Mysimba is already approved for use. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Mysimba?

Mysimba is a medication that's already approved for weight management. It contains two medicines, naltrexone and bupropion, which work on parts of your brain involved in appetite and reward.

What is 'weight regain' after surgery?

It means gaining back some weight after an initial period of weight loss following bariatric (weight-loss) surgery.

How long will the study last?

The study will last for approximately 22 weeks.

Do I have to take Mysimba if I join?

You might receive Mysimba or you might receive only healthy lifestyle advice. It's decided randomly, so you won't get to choose which group you are in.

Who is running this study?

This study is being conducted by researchers to better understand how to help people who have regained weight after bariatric surgery.