Active not recruitingPHASE1INTERVENTIONAL

A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector

This research study is looking into a new medicine called survodutide. We want to understand if two different forms of survodutide, given using either a pre-filled syringe or a pen-like injector, are absorbed by the body in the same way. The study includes healthy volunteers and people who are healthy but also have overweight or obesity. This is a very early stage (Phase 1) study, meaning it's focused on how the medicine acts in the body rather than its full effects. Participants will visit the study site regularly for health checks and blood tests to help us gather information about the medicine.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

03 Mar 2026

Estimated completion

08 Jun 2026

Healthy Obesity

What is this study about?

This study is about a new medicine called survodutide. We're trying to find out if different ways of giving this medicine to people result in the same amount of medicine getting into the body. Think of it like comparing two slightly different recipes for a cake – we want to know if they both turn out the same way. In this case, we're comparing two forms of survodutide, given either with a simple pre-filled syringe or a pen-like injector, to see if they are equally good at delivering the medicine.

The main goal is to check how the body takes in and uses survodutide from these two different methods. This information is really important because it helps scientists decide the best way to give new medicines in the future, making sure they work as intended. This isn't about whether survodutide helps with weight loss or other conditions yet; it's a first step to understand the basics of how the medicine behaves.

By taking part, you’d be helping doctors learn more about survodutide and how to best develop it for potential future uses. Your contribution helps us get closer to understanding this new medicine better.

Key takeaways

This study compares two ways of giving a new medicine called survodutide.
The goal is to see if different injectors deliver the medicine similarly in your body.
It's a very early-stage study, focusing on how the medicine works, not its full effects.
Participants must be generally healthy, aged 18-55, with a specific BMI range.
Regular health checks and blood tests are part of taking part.
Your contribution helps scientists understand new medicines better.

Who may be eligible?

To join this study, you need to be a healthy man or woman between 18 and 55 years old. This means a doctor would check your overall health and confirm you don't have any significant medical problems.

Your Body Mass Index (BMI) also needs to be between 22.0 and 39.9. BMI is a measure that uses your height and weight to see if you're a healthy weight. If you're generally healthy but your BMI falls into the overweight or obesity range, you could still be eligible.

However, you wouldn't be able to join if you have any serious health issues, like unusual blood pressure, a very fast or slow heart rate, or any other medical condition that the study doctor thinks could make it unsafe for you to take part.

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 55 years old?
Are you generally healthy, with no major ongoing medical conditions?
Is your Body Mass Index (BMI) between 22.0 and 39.9?
Are you comfortable with regular health checks and blood tests?
Have you discussed any existing health concerns with your doctor?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll need to visit the study site regularly. During these visits, doctors and nurses will check your health, which includes things like your blood pressure, heart rate, and a general physical check-up. You'll also have blood samples taken regularly. This is to help us understand how the survodutide medicine is working in your body. We don't have the exact number of visits or the total length of the study from this information, but this will be fully explained to you before you agree to take part.

Potential risks and benefits

Taking part in a study like this could offer a potential benefit of contributing to medical knowledge and potentially helping develop new treatments in the future. However, there are also potential risks, such as discomfort from blood tests or possible side effects from the study medicine, which will be fully explained. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Humanpharmakologisches Zentrum Biberach
Verified postcode
Biberach, Germany

Common questions

What is survodutide?

Survodutide is a new medicine being studied. This particular study is looking at how it behaves in the body, not its full effects yet.

What's the difference between a pre-filled syringe and a pen-like injector?

Both are ways to give medicine by injection. A pre-filled syringe is a common, ready-to-use needle and syringe. A pen-like injector is often designed to make injections easier, sometimes with a dial to set the dose.

Will I know if I'm getting formulation A or B2?

This information isn't provided, but in studies like this, participants are often assigned to one group and may not know which specific formulation they are receiving.

What will happen during the study visits?

During your visits, doctors will check your general health, including blood pressure and heart rate, and you'll have blood samples taken regularly to see how the medicine is working.

Is this medicine meant for weight loss?

This specific study is about how the medicine is absorbed by the body. While it's being studied in people with overweight or obesity, this early phase is not directly testing its effects on weight loss.