Semaglutide 2.4 mg in Patients With Poor Weight-loss
Researchers are conducting a study to see if a medication called semaglutide (at a dose of 3mg) can help individuals who have had weight-loss surgery (gastric bypass or sleeve gastrectomy) but haven't lost as much weight as hoped. The study will involve giving some participants semaglutide and others a dummy treatment (placebo) for 68 weeks. The aim is to find out if semaglutide leads to greater weight loss, reduces body fat, improves health markers related to sugar and fats in the body, and boosts overall quality of life. This is a blinded study, meaning neither the participants nor their doctors will know who is receiving semaglutide and who is receiving the placebo, ensuring fair results.
At a glance
What is this study about?
Imagine you've had weight-loss surgery, like a gastric bypass or sleeve gastrectomy, hoping it would help you reach a healthier weight, but you haven't seen quite the results you expected. This study is looking into a medicine called semaglutide to see if it can offer extra help in such situations. Semaglutide is already used for some people with type 2 diabetes and obesity, and this research aims to understand if a specific dose, given as an injection, can further support weight loss after surgery.
This is a 'Phase 3' study, which means it's one of the final steps before a medicine might be approved for wider use. The main goal is to compare semaglutide to a 'placebo' – a dummy treatment that looks just like the real medicine but contains no active drug. This helps researchers understand if any benefits seen are truly due to semaglutide or other factors. Both the people taking part and their doctors won't know whether they're getting the active drug or the placebo. This setup ensures the results are as unbiased and reliable as possible.
Over 68 weeks, researchers will carefully measure how much weight people lose, changes in body fat, and improvements in health factors related to how your body handles sugar and fats. They'll also look at how people's quality of life changes, thinking about how they feel physically and mentally. The hope is that this study will provide clear answers on whether semaglutide can be a valuable option for people who need more support with weight loss after bariatric surgery.
Key takeaways
- Study compares semaglutide to a dummy treatment for weight loss after bariatric surgery.
- Aims to improve weight loss, body fat, and overall health.
- Study lasts for 68 weeks (about 15 months).
- Neither you nor your doctor will know if you're getting the active drug or placebo.
- Participation involves regular clinic visits and health checks.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you generally need to be an adult between 18 and 65 years old. You must have had either a gastric bypass or sleeve gastrectomy at least one year ago, and not have lost as much weight as hoped (less than 20% of your starting weight). It's important that this slower weight loss isn't due to another surgery problem or a psychological issue.
There are also some important things that would prevent you from taking part. For example, if you've had a different type of weight-loss surgery, or if you have type 1 diabetes or type 2 diabetes treated with insulin, you wouldn't be able to join. You can't be pregnant, breastfeeding, or planning to get pregnant. People with certain serious health conditions, including severe uncontrolled high blood pressure, significant kidney problems, or a history of recent suicidal thoughts, would also not be eligible.
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 between 18 and 65 years old?
- Did you have gastric bypass or sleeve gastrectomy at least one year ago?
- Have you lost less than 20% of your starting weight since surgery?
- Are you not pregnant, breastfeeding, or planning to become so?
- Do you not have type 1 diabetes or type 2 diabetes requiring insulin?
- Do you not have certain serious medical conditions like uncontrolled high blood pressure or significant kidney problems?
What does participation involve?
If you join this study, you'll be assigned by chance (like flipping a coin) to either receive the study medicine (semaglutide) or a dummy treatment (placebo). You'll receive this as an injection under the skin for 68 weeks, which is about 15 months. Neither you nor your study doctor will know which treatment you are receiving until the study is over.
Throughout these 68 weeks, you'll have regular visits to the clinic where you'll have assessments. These will include checking your weight, blood pressure, and having blood tests to look at various health markers. You'll also be asked to fill out questionnaires about your health and how you're feeling, to help understand your quality of life. The study will monitor your progress and health closely. After the 68 weeks of treatment, there will likely be some follow-up visits to see how you are doing.
Potential risks and benefits
Locations (1)
- Janine MakaronidsVerified postcodeLondon, United Kingdom
Common questions
What is semaglutide?
Semaglutide is a medication that helps control blood sugar and can also lead to weight loss, and it's given as an injection.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the real medicine's effects accurately.
How long will the study last?
The main treatment period for the study is 68 weeks, which is about 15 months.
Will I know if I'm getting semaglutide or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study has finished.
Can I stop participating in the study if I want to?
Yes, you are free to leave the study at any time, for any reason, and it will not affect your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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