Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to test how well different doses of BI 3034701 are tolerated by healthy men and people with overweight or obesity

This research is a 'Phase 1' study, which means it's one of the first times this new medicine, called BI 3034701, is being given to people. The main goal is to find out how well healthy men and people who are overweight or obese tolerate different doses of the medication. We'll be looking carefully at any side effects and how the body handles the medicine. This helps doctors understand what a safe dose might be for future studies. Taking part would involve a few visits and tests, and you'd be helping to advance medical knowledge.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

125

Start

22 Apr 2024

Healthy volunteer trial

What is this study about?

Imagine scientists have developed a new key, and now they need to see if it fits the lock and how it works. This study is very much like that for a new medicine called BI 3034701. It's the very first time this medicine is being given to people, a stage we call 'Phase 1'. The main aim isn't to treat a specific illness yet, but to carefully watch how the human body reacts to different amounts of this new medicine.

We're mainly interested in two things: how well people tolerate the medicine, meaning if they have any side effects, and how their body processes it. This involves giving a small group of healthy men and people who are overweight or obese different doses and then closely monitoring them. Think of it like a very careful test drive for a new car – we want to make sure it runs smoothly before it carries lots of passengers.

The information we gather from this study is incredibly important. It helps us understand if the new medicine is safe enough to be tested in larger groups of people in the future, and what the right amount to give might be. Your participation helps lay the groundwork for potentially developing new treatments further down the line.

Key takeaways

This is a 'first-in-human' study for a new medicine.
The main goal is to check safety and how the medicine is tolerated.
Both healthy men and people who are overweight or obese can join.
Participation involves multiple visits and close medical monitoring.
You can stop participating at any time.
Your involvement helps advance future medical treatments.

Who may be eligible?

This study is looking for both healthy men and people who are overweight or obese to take part. It's important that you are generally well and meet certain health criteria to ensure it's safe for you to participate.

You must be 18 years old or older to be considered. There's no upper age limit, but your overall health will be checked carefully. Both men and women can join this study.

There will be other detailed health checks to make sure you're suitable and that taking part won't put your health at risk. These checks are important to keep participants safe and get reliable results.

Quick self-check

Are you 18 years old or older?
Are you generally healthy, or do you fit the 'overweight or obese' criteria for the study?
Are you able to attend regular clinic visits, potentially with overnight stays?
Are you willing to have medical tests like blood and urine samples?
Are you comfortable taking a new, experimental 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'll first have a screening visit. This is where doctors will check your general health, blood pressure, and take blood and urine samples to make sure you're suitable for the study. If you qualify, you'll be given the new medicine, BI 3034701. You will be closely monitored by medical staff for a period after receiving the medicine.

Participation will involve several visits to the clinic, which could include overnight stays depending on the specific group you're in. During these visits, medical staff will routinely check your vital signs, take blood and urine samples, and ask you about how you're feeling and any side effects you might be having.

The total duration of your involvement could vary, but typically Phase 1 studies involve a period of treatment followed by a series of follow-up visits to ensure the medicine has left your system and you are well. Your study doctor will explain the exact schedule and duration relevant to your participation.

Potential risks and benefits

Potential benefits of participating include contributing to medical research that could help develop new medicines in the future. You will also receive careful medical monitoring throughout the study. However, there's always a possibility of unknown side effects when trying a new medicine for the first time. These could range from mild discomfort to more serious reactions. You will be fully informed of all known potential risks before you consent to take part. It's important to remember that you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is a Phase 1 study?

It's the first time a new medicine is given to people. Doctors check its safety and how the body handles it.

Will this medicine treat my condition?

No, this study is about checking safety and how the medicine works, not treating any specific illness yet.

What kind of tests will I have?

You'll have health checks, blood and urine tests, and your vital signs monitored regularly.

How long will I be in the study?

The exact time varies, but it includes taking the medicine, monitoring visits, and follow-up checks.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.