Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in people with overweight or obesity to test how BI 1820237, BI 456906, or a combination of both affects brain activity

This research study is for adults who are overweight or have obesity. Scientists are investigating two new medicines, called BI 1820237 and BI 456906. The main goal is to see how each of these medicines, or a combination of both, might change activity in the brain. By looking at brain activity, researchers hope to understand more about how these medicines work and their potential role in managing weight. This is an early-stage study, meaning it's one of the first times these specific medicines are being tested in people. It will help us understand their basic effects and safety before they can be studied in more detail.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

20 Mar 2024

Obesity

What is this study about?

This research study is about understanding how certain new medicines might affect the brain in people who are overweight or have obesity. The two medicines being tested are called BI 1820237 and BI 456906. Researchers want to see if taking one of these medicines, or a combination of both, changes how the brain works. This type of early study is important because it helps scientists learn more about how potential new treatments interact with the body, especially the brain, which plays a key role in weight management.

Being overweight or living with obesity can affect many aspects of a person's health. Scientists are continuously looking for new and effective ways to help manage weight, and understanding how medicines affect the brain is a crucial part of this research. By studying brain activity, researchers hope to gain insights into how these new medicines might influence appetite, metabolism, or other brain functions related to weight.

This is an early-stage trial, sometimes called a Phase I study. This means it's one of the first times these particular medicines are being given to people. The main focus at this stage is to check that the medicines are safe and to understand how they work in the body, including any effects they have on the brain. The information gathered from this study will help determine if these medicines should be explored further in larger studies, moving us closer to potentially new ways to help people living with obesity.

Key takeaways

This study explores new medicines for overweight or obesity.
It focuses on how these medicines affect brain activity.
It's an early-stage study (Phase I) checking safety and how the medicines work.
Open to adults aged 18 and over who are overweight or have obesity.
Participation involves taking study medicine and attending regular check-ups.
Joining is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 years and older. Both men and women can take part. To be considered, you must be someone who is currently overweight or has obesity. There will be specific health checks and criteria that are not listed here, to make sure the study is safe and appropriate for you.

It's important to remember that not everyone who is overweight or has obesity will be able to join. For example, if you have certain other health conditions, are taking particular medications, or have a history of specific illnesses, you might not be eligible. The research team will carefully review your medical history to make sure you fit all the necessary requirements for the study.

If you're interested, the doctors involved will explain all the requirements in detail and answer any questions you might have. They will ensure taking part is suitable and safe for you.

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 18 years old or older?
Are you currently considered overweight or living with obesity?
Are you generally in good health, apart from being overweight or having obesity?
Are you able to attend regular clinic visits for checks and tests?
Are you willing to potentially take a new, untried medicine (or a dummy pill)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit where doctors would check your health and suitability. If you qualify, you would then be given one of the study medicines (BI 1820237, BI 456906, or a combination) or a placebo (a dummy medicine with no active ingredients). This early study typically involves careful monitoring over a period, which might include several visits to a clinic. During these visits, you might have blood tests, brain scans, or other assessments to see how your body and brain are responding to the medicine.

Study medicines would be provided, and you would be told how and when to take them. The total duration of your involvement could range from a few weeks to a couple of months, depending on the specific design of the study. You would have regular check-ups to monitor your health and any side effects. All procedures would be explained fully before you agree to take part.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be contributing to important scientific knowledge that might help develop new treatments for obesity in the future. You would also receive careful medical monitoring throughout the study. However, there's no guarantee that you will personally benefit from taking the study medicine. Potential risks might include side effects from the study medicines, which could range from mild to more serious, although early-stage studies are designed to be as safe as possible. There could also be discomfort or inconvenience from tests and visits. It is very important to remember that joining a study is always voluntary, and you are free to withdraw at any time for any reason without it affecting your medical care.

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 are BI 1820237 and BI 456906?

These are new potential medicines that are currently being tested in people for the first time. They are not available as treatments yet.

What exactly will they measure in my brain?

They will likely use special scans or other techniques to look at brain activity and how the medicines might affect it. The exact tests will be explained by the study team.

Will this study help me lose weight?

The primary goal of this early study is to understand how the medicines affect brain activity and their safety, not necessarily to cause weight loss. Any weight changes would be noted, but it's not the main aim at this stage.

Do I have to pay to join the study?

No, you should not have to pay to take part in a clinical trial. All study-related care and medicines are typically provided free of charge.

What is a 'Phase I' study?

A Phase I study is an early stage of research where new medicines are first tested in a small group of people to assess their safety and how they work in the body.