AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study to compare how survodutide is taken up by the body when given in 2 formulations to people with overweight or obesity

This clinical trial is studying an experimental medicine called survodutide, which is being developed to help treat overweight and obesity. Researchers have created two different versions, or formulations, of this medicine. The main goal of this early-stage study is to see whether the body takes up both versions in the same way. Taking part helps scientists understand the exact path the medicine takes through the bloodstream, how quickly it works, and how safe it is. The study is open to adults aged 18 and older who are living with overweight or obesity and are otherwise in good health. Participants will receive study medication, attend regular clinic visits, and have health checks like blood tests. Taking part is completely voluntary, and doctors closely supervise everyone involved.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

12 Oct 2026

Healthy volunteer trial

What is this study about?

Survodutide is a medicine currently being researched to help people manage their weight. In order to make medicines as effective and easy to use as possible, scientists sometimes design different ways to make or deliver them. In this trial, researchers are comparing two different versions of survodutide to check if the human body absorbs, processes, and clears them in the exact same way.

This type of research is called a Phase 1 bioequivalence study. When a medicine enters this early stage, researchers focus mainly on understanding how it behaves inside the body rather than testing how well it works over many months or years. By measuring the medicine in the blood over time, doctors can ensure that any new version works just as reliably as the original.

Finding safe, effective treatments for obesity is important because living with excess weight can increase the risk of other long-term health problems, such as type 2 diabetes and heart disease. By volunteering for a study like this, participants help scientists gather the clear facts needed to decide if this medicine can move forward into larger, longer trials.

Key takeaways

Tests how the body absorbs two different versions of the drug survodutide.
Open to adults aged 18 and older who are overweight or have obesity.
Early-stage Phase 1 trial focused on safety and blood measurements.
Requires regular clinic visits and frequent blood tests.
Completely voluntary with the freedom to leave at any time.

Who may be eligible?

This trial is looking for adults aged 18 and over who have a higher body weight, falling into the categories of overweight or obesity. Both men and women can apply. Because this is an early-stage study, volunteers are generally expected to be in good overall health apart from their weight.

People with significant underlying medical conditions, such as severe heart problems, uncontrolled diabetes, or kidney disease, will likely not be able to take part. This is to ensure participant safety and make sure test results are clear and reliable.

If you are pregnant, planning to become pregnant, or taking certain regular prescription medicines, you may also be excluded. A full medical screening will take place before anyone joins the study to confirm it is safe for them to participate.

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.

I am at least 18 years old.
I have a body weight that is considered overweight or obese.
I am in generally good health without severe organ or heart disease.
I am not currently pregnant or breastfeeding.
I am willing to attend clinic visits and give blood samples.

Answer every question to see your result.

What does participation involve?

If you take part, you will first attend a screening visit where doctors check your health with physical exams, blood tests, and heart tracings (ECGs). Once accepted, you will receive doses of survodutide in its two different forms, usually given at separate times so researchers can compare the results.

You may need to stay at the clinic overnight or make several day visits so the study team can take blood samples at set times. These tests measure the exact amount of medicine in your body. The team will also monitor your blood pressure, heart rate, and any changes in how you feel. The total study duration will typically last a few weeks to a few months, and you will have a final check-up at the end to make sure you are well.

Potential risks and benefits

You may not get any direct health benefit from taking part, as this study is designed to gather scientific information rather than provide long-term weight loss. However, your involvement could help improve future treatments for people living with obesity. All medicines carry a risk of side effects, which might include mild stomach upset, nausea, or headache, as well as temporary discomfort from blood tests. The medical team will monitor you closely at all times to keep you safe. You have the right to withdraw from the study at any point without giving a reason and without affecting your normal healthcare.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is the purpose of this study?

The study checks how the body takes up two different versions of the medicine survodutide to confirm they work the same way.

Will taking part help me lose weight permanently?

Probably not. This is a short-term trial focused on how the drug moves through the body, not a long-term weight-loss treatment plan.

Do I have to pay to take part?

No, you do not pay for study visits, tests, or medication. Trials often cover travel expenses or compensate for your time.

How is the medicine given?

Medicines in this class are typically given by an injection under the skin, but the study team will explain the exact method before you start.

Can I leave the study if I change my mind?

Yes, you can leave at any time without penalty or any change to your standard NHS care.