Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Young adults with early-onset obesity treated with semaglutide -The RESETTLE study - a randomized double blind placebo-controlled clinical trial

The RESETTLE study is investigating a medicine called semaglutide for young adults who developed obesity early in life. This study is a type of research where some people get the actual medicine and others get a dummy medicine (placebo), without anyone knowing who gets what. The main goal is to see how much semaglutide changes a person's Body Mass Index (BMI) compared to the dummy medicine. Researchers will also look at changes in body fat, overall weight, and how many people achieve significant weight loss (5%, 10%, 15%, or 20% of their body weight). This is a 'Phase IV' study, meaning the medicine is already approved for some uses, but researchers want to understand more about its effects in this specific group.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Kobenhavns Universitet

Enrolment target

255

Start

02 Oct 2024

Obesity

What is this study about?

This study, called RESETTLE, is looking at a medicine named semaglutide for young adults who have been living with obesity from a younger age. Obesity is a medical condition where you carry excess body fat, which can affect your health. The study wants to understand if semaglutide can help these young adults manage their weight more effectively compared to not receiving the active medicine.

To ensure fair results, this is a 'blinded' study. This means that neither you nor your study doctor will know whether you are receiving the actual semaglutide medicine or a dummy medicine, called a placebo. This helps prevent any bias and allows researchers to see the true effects of the medicine. The main thing they will measure is your Body Mass Index (BMI), which is a way to check if your weight is healthy for your height. They'll compare BMI changes in those who took semaglutide versus those who took the placebo.

Beyond just BMI, the researchers will also be interested in other aspects of your health. They will look at changes in your body composition (how much fat and muscle you have), overall body weight, and track how many participants achieve different levels of weight loss, such as losing 5%, 10%, 15%, or even 20% of their starting weight. This information will help doctors understand the full picture of how semaglutide might help young adults with obesity.

Key takeaways

The RESETTLE study is for young adults with early-onset obesity.
It tests semaglutide against a dummy medicine (placebo).
The main goal is to see how your weight and BMI change.
Both men and women aged 18 and over can take part.
Your health will be closely monitored throughout the study.
You can leave the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, meaning 18 years old or older. There is no upper age limit for taking part.

Both men and women are welcome to participate in this research. The study is specifically for individuals who have been diagnosed with obesity that started when they were younger.

While the main criteria are your age range and the condition of obesity, detailed eligibility checks will be done by the study team to ensure the study is safe and suitable for everyone involved. They will ask more questions about your health and medical history to make sure you fit all the requirements.

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 been told you have obesity that started when you were younger?
Are you able to attend regular study appointments?
Are you comfortable not knowing if you're getting the active medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the RESETTLE study, you would typically begin by having an initial assessment where doctors check if the study is right for you. If you qualify, you would then be assigned to either receive the semaglutide medicine or a placebo (dummy medicine). You wouldn't know which one you're taking.

You would need to attend several appointments at the study clinic. During these visits, doctors and nurses would take measurements like your weight, height, and check your overall health. They might also take blood samples and perform scans to assess your body composition (how much fat and muscle you have).

You would regularly take the study medication as instructed for a set period. There would be follow-up appointments to monitor your progress, check for any side effects, and see how your body is responding to the treatment. The total length of your participation, including all visits and follow-ups, would be explained to you in detail before you agree to join.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of receiving a medicine that might help with weight management. It also contributes to scientific understanding that could help others in the future. However, there are potential risks, as with any medication. Semaglutide can have side effects, which the study team would explain, and some people may experience side effects from the placebo, or the medication may not work for them. Your health will be closely monitored throughout the study. It's very important to remember you can leave the study at any time, for any reason, without it affecting your 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
Denmark

Common questions

What is semaglutide?

Semaglutide is a medicine that helps manage blood sugar levels and can also help with weight loss in some people.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers see the true effect of the active medicine.

What does 'early-onset obesity' mean?

It means that obesity developed when someone was younger, rather than later in life.

Will I know if I'm getting the real medicine?

No, in this type of study, neither you nor your doctor will know whether you are receiving the real medicine or the placebo.

What is BMI and why is it measured?

BMI stands for Body Mass Index. It's a simple calculation based on your height and weight to give an idea of whether your weight is healthy for your height. It's a key measurement in this study.