A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
This study is for healthy people aged 18 to 65 who have a body mass index (BMI) between 27 and 39.9. We're testing a new version of a potential medicine called survodutide. This medicine is being developed to help people with obesity and certain liver conditions. The main goal is to understand how well this new version of survodutide is absorbed and used by the body. Participants will be split into two groups, receiving either the standard survodutide or the new version. Both groups will get weekly injections under the skin for about 6 and a half months. Over the 7-month study, you'll have 15 visits, including one 3-night stay, for blood tests and health checks.
At a glance
What is this study about?
Imagine you have a new mobile phone, and the company makes a slightly updated version of it. Even if the update seems small, they need to check if it works just as well, or even better, than the original. That's a bit like what this study is doing with a medicine called survodutide.
Survodutide is a medicine that scientists are developing to help people who are overweight (obese) and people with certain liver problems. In this study, we're testing a slightly different way this medicine has been made, called a 'new formulation'. The main reason for this study is to understand how the body takes in and uses this new version compared to the original one.
This is a very early stage study, which means we're still gathering basic information. By involving healthy volunteers, we can carefully see how the medicine acts in the body without other health conditions getting in the way. The information we learn here will help decide if this new version of survodutide could be a good option for future studies in people with obesity or liver conditions.
Key takeaways
- This study tests a new version of survodutide, a medicine for obesity and liver conditions.
- It's open to healthy people aged 18-65 with a BMI between 27 and 39.9.
- Participants will have weekly injections for 6.5 months and 15 clinic visits over 7 months.
- One visit includes a 3-night stay for detailed health checks and blood samples.
- The main goal is to see how the new medicine is absorbed by the body.
- Your participation helps advance knowledge about this potential new treatment.
Who may be eligible?
To join this study, you need to be a healthy person between 18 and 65 years old. Doctors will check your general health, including your blood pressure, heart rate, and blood tests, to make sure you're well enough to take part. Your Body Mass Index (BMI), which is a measure of your weight compared to your height, needs to be between 27 and 39.9.
There are also some reasons why you might not be able to join. For example, if you have any health issues that the study doctor thinks are important, or if your blood pressure, heart rate, or blood test results fall outside specific healthy ranges. If you have conditions like high blood pressure, an underactive thyroid, gout, or high cholesterol, you might still be able to join if these conditions are well-managed and your doctor agrees.
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?
- Is your Body Mass Index (BMI) between 27 and 39.9?
- Are you generally healthy, with no significant ongoing medical conditions?
- Is your blood pressure usually within a healthy range (not too high or too low)?
- Are you comfortable with regular blood tests and giving yourself injections?
What does participation involve?
If you join this study, you'll be in it for about 7 months in total. You'll be assigned by chance to one of two groups: one group will receive the standard survodutide, and the other will receive the new version. In both groups, you'll give yourself an injection of survodutide under your skin once a week for roughly 6 and a half months.
During these 7 months, you'll need to visit the study clinic 15 times. One of these visits will involve staying overnight at the clinic for 3 nights. During your visits, the study team will take blood samples to measure how much survodutide is in your blood. They will also regularly check your general health and keep a careful record of any side effects or unexpected feelings you might have.
Potential risks and benefits
Locations (2)
- CRS Clinical Research Services Berlin GmbHVerified postcodeBerlin, Germany
- CRS Clinical Research Services Mannheim GmbHVerified postcodeMannheim, Germany
Common questions
What is survodutide?
Survodutide is a new medicine being developed to help people with obesity and certain liver conditions.
Who can join this study?
Healthy people aged 18-65 with a BMI between 27 and 39.9, and who meet other health requirements, can join.
What will I have to do if I join?
You'll have weekly injections for about 6.5 months, attend 15 clinic visits over 7 months, including one 3-night stay, for blood tests and health checks.
Will I know if I'm getting the new version of the medicine?
No, you'll be assigned to a group by chance, and neither you nor the study team will know which version you are receiving.
Why use healthy people for this study?
Using healthy volunteers helps researchers understand how the medicine works in the body without other health conditions making it harder to interpret results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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