RecruitingPHASE1INTERVENTIONAL

A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body

This research study is for healthy people aged 18 to 65 who are overweight or have obesity. We want to understand how two slightly different versions of a new medicine, called survodutide, are absorbed and used by the body. We'll give participants one of these versions and then carefully check how it moves through their system. The main goal is to see if these two versions behave in a similar way when they are taken repeatedly over time. This helps us ensure that any future treatments developed from this medicine are consistent and work as expected. Your involvement would help researchers learn more about potential new treatments for weight management.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

26 Feb 2026

Estimated completion

02 Mar 2027

Healthy Obesity Overweight

What is this study about?

This study is exploring a new medicine called survodutide, which is being developed to help people who are overweight or have obesity. Imagine a medicine can be made in slightly different ways. This study specifically wants to see if two different versions of survodutide, which we're calling Formulation A and Formulation B6, are handled in the same way by your body. Think of it like comparing two slightly different recipes for the same cake – they might look a bit different, but do they taste exactly the same in the end? That's what we're trying to find out with this medicine.

The main purpose is to make sure that these two versions of survodutide are 'bioequivalent'. This simply means they are absorbed into your bloodstream at a similar speed and to a similar amount. Why is this important? If one version is significantly different from the other, it could affect how well the medicine works or if it causes any side effects. By understanding this now, researchers can ensure that future studies and eventual treatments using survodutide are safe and effective, no matter which precise formulation is used.

Your participation would help researchers gather crucial information about this potential new treatment. This kind of early-stage research is vital for developing new medications that could one day help many people manage their weight more effectively. It's a foundational step to ensure consistency and reliability in new medicines.

Key takeaways

This study is testing two versions of a new medicine for weight management.
It aims to see if these two versions are taken up by the body in the same way.
You must be generally healthy, aged 18-65, and have a BMI between 27 and 39.9.
Women who can become pregnant must use highly effective birth control.
Participation involves regular clinic visits, blood tests, and health checks.
Your contribution helps develop new medicines for obesity and overweight.

Who may be eligible?

To join this study, you need to be a healthy man or woman between 18 and 65 years old. The research team will do some checks to make sure you're generally healthy, including a physical exam, a heart tracing (ECG), and blood tests. You also need to have a Body Mass Index (BMI) between 27 and 39.9, which means you are considered overweight or to have obesity.

If you are a woman who could become pregnant, there are specific contraception requirements. You'll need to be using a highly effective method of contraception from four weeks before the study starts until four weeks after it finishes. This is to ensure you don't become pregnant while taking the study medicine, as we don't yet know its effects on unborn babies.

Examples of highly effective contraception include certain types of birth control pills, injections, implants, or coils (IUD/IUS). If you usually rely on methods like the rhythm method or just spermicides, these won't be suitable for this study. If you're unsure about your contraception, the study team can explain the requirements in more detail.

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?
Do you have a Body Mass Index (BMI) between 27 and 39.9?
Are you generally healthy, with no major ongoing illnesses?
If you are a woman who can get pregnant, are you willing to use effective birth control for the study duration and beyond?
Are you able to attend all clinic appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive either Formulation A or Formulation B6 of survodutide over several doses. The study involves regular visits to the clinic where the research team will monitor your health, take blood samples to measure how the medicine is behaving in your body, and perform other tests like checking your blood pressure and heart rate. You'll also have a physical examination at the start and end of the study. The total length of your participation in the study, from your first dose until the final follow-up, will be explained to you in detail by the study team. You'll need to follow specific instructions about taking your medicine and attending all scheduled appointments.

Potential risks and benefits

Participating in this study might offer some potential benefits, as you'll be contributing to important medical research that could lead to new treatments for weight management. However, there is no guarantee that you will personally benefit directly from taking the study medicine. As with any medicine, there's a chance of side effects, which will be carefully explained to you before you agree to take part. The study team will closely monitor you throughout for any unexpected effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Quotient Sciences
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is survodutide?

Survodutide is a new medicine being developed to help people who are overweight or have obesity. This study is an early step in understanding it better.

What does 'bioequivalence' mean?

It means that two different versions of a medicine are absorbed into your body in a very similar way, at a similar speed and amount.

Will I know which formulation I'm getting?

This study is 'blinded', which usually means neither you nor the study doctors will know which specific formulation you are receiving until after the study is complete. This helps keep the results unbiased.

Are there any costs involved for me?

You will not have to pay for the study medication or any study-related tests or visits. Travel expenses or other related costs might be covered, but you should confirm this with the study team.

What if I change my mind about participating?

You can withdraw from the study at any time, for any reason, without losing any regular medical care.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.