Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy people to compare how 3 different formulations of survodutide are taken up in the body

This study is for healthy volunteers and aims to understand how a new medicine, survodutide, behaves in the body. We are testing three slightly different ways to give this medicine to see which one is absorbed best. This initial research, called a Phase I study, is very important because it helps scientists figure out the best way to develop new treatments. By taking part, you’d be helping us learn how the medicine enters your bloodstream and how long it stays there. This information is crucial for making sure that future patients get the right amount of medication in the most effective way.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

13 Dec 2024

Healthy volunteer trial

What is this study about?

This study is a very early step in developing a new medicine called survodutide. In these first-stage studies, we're not looking at treating a specific illness, but instead, we're trying to understand the basics of how the medicine works in the human body. Think of it like testing different ways to deliver a package: we want to see which delivery method gets the package (the medicine) into your system most efficiently.

Specifically, researchers want to compare three slightly different versions, or 'formulations,' of survodutide. Each formulation might be absorbed by your body in a slightly different way. By seeing how each one is taken up, how quickly it enters your blood, and how long it stays there, scientists can choose the best design for the medicine. This is a crucial step towards making sure that when survodutide is eventually used to treat illnesses, it is given in the most effective and safest way possible.

This kind of study helps us understand how a new medicine interacts with the body before it's given to people who are unwell. It provides essential information to ensure that future studies and treatments are based on a solid understanding of the medicine's properties. Your participation helps lay the groundwork for potential new treatments for various conditions.

Key takeaways

This study is testing a new medicine called survodutide in healthy people.
It aims to see how different forms of the medicine are absorbed by the body.
Participation helps scientists develop potential future treatments.
You must be a healthy adult, aged 18 or over.
There will be hospital visits and health checks, including blood tests.

Who may be eligible?

This study is open to both men and women who are generally fit and well. You need to be at least 18 years old to take part. There isn't an upper age limit mentioned, but you will undergo a health check to make sure you're suitable.

The main thing is that you should be a 'healthy volunteer.' This means you don't have any major ongoing health conditions or take regular medications for them. The research team will do a full check-up to make sure this study is safe for you.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy with no major ongoing medical conditions?
Are you able to attend regular hospital visits for health checks and blood tests?
Are you comfortable potentially receiving an investigational new medicine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will first have a screening visit to check your general health. This will involve a physical examination, blood tests, and perhaps other checks to make sure you meet the study's requirements. If you're suitable, you'll be given the study medicine (survodutide) on specific occasions.

During your time in the study, you'll have regular hospital visits. These visits will involve having blood samples taken to measure how much of the medicine is in your body over time, and you'll also have other health checks to make sure you're doing well. The timing and number of visits will be explained in full, as will the total duration of your involvement in the study, including any follow-up appointments.

Potential risks and benefits

Participating in a study like this helps advance medical research for future treatments, which can be a rewarding feeling. However, as with any medicine, there's always a chance of side effects, even in healthy people. These might be mild, like a headache, or could be more serious, though serious side effects are rare in early-stage studies and are closely monitored. All potential risks will be thoroughly explained before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is survodutide?

Survodutide is a new medicine that is being tested. This study is an early step to understand how it works in the body, not to treat an illness yet.

Why are there different 'formulations'?

Different formulations are slightly varied ways the medicine is made or given. We test them to find out which one gets absorbed into your body most effectively.

Will I get paid for taking part?

Information about payment or reimbursement for your time and travel will be fully explained by the study team if you inquire about joining.

Will I know if I'm getting the actual medicine or a dummy pill?

This study is comparing different versions of the actual medicine, not a dummy pill (placebo). You will receive one of the survodutide formulations.

How long will I be in the study?

The total length of your participation, including visits and follow-up, will be clearly explained by the study team during the consent process.