Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Track How the Healthy Male Participants Handles the New Oral Drug RO7795081 for Weight Management and Diabetes

This research is an early-stage study, called a Phase I trial, testing a new oral medication named RO7795081. The main goal is to understand how healthy male volunteers' bodies process this new drug, how much of it gets into their system, and how it's eventually removed. This particular drug is being investigated for its potential to help manage weight and diabetes. By studying healthy men first, researchers can gather important safety information and learn more about the drug's basic effects before it's tested in people with the actual conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

11 Feb 2026

Not Applicable

What is this study about?

This study is about a brand new medicine, called RO7795081, that you would take by mouth. It's hoped this drug might one day help people manage their weight and diabetes. Right now, this is a very early test, sometimes called a 'Phase I' study. Think of it as the first step in a long journey of testing new medicines.

The main aim of this particular study is to see how the new drug behaves in the bodies of healthy men. Researchers want to understand exactly how the drug is absorbed, how it travels through the body, and how it's eventually cleared out. This information is crucial for making sure any new medicine is safe and that future studies can be designed properly. They're not looking to treat diabetes or weight in this study, but simply to observe how healthy bodies react to the drug.

Because it's such an early stage, this study is focused purely on understanding the drug itself in healthy people, rather than testing its effects on a specific condition like diabetes or obesity. It's a vital step to gather initial safety information and learn the basics about how the drug works before it can be explored further for its potential health benefits.

Key takeaways

This is an early-stage study of a new oral drug, RO7795081.
It's being tested in healthy men.
The study aims to understand how the drug works in the body.
The drug is being developed for weight management and diabetes.
Participation will involve clinic visits and medical checks.

Who may be eligible?

To join this study, you need to be a man.

Your age must be 18 years old or above. There isn't an upper age limit mentioned, so men of many different ages could potentially take part.

Importantly, this study is looking for healthy men. This means you shouldn't have any major ongoing health conditions. The researchers will check your health carefully to make sure it's safe 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 a man?
Are you 18 years old or older?
Are you generally healthy?
Are you willing to commit to regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would likely need to make several visits to a clinic. During these visits, the research team would give you the new drug, RO7795081, to take. They would then carry out a series of assessments, which might include taking blood or urine samples to see how your body is handling the drug.

You might also have measurements taken, such as your blood pressure or heart rate. The team will carefully monitor you for any changes or side effects. The total length of your involvement in the study, including any follow-up checks, would be explained to you in detail before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this early-stage trial, a direct personal health benefit is unlikely, as the main goal is to gather information about the drug. However, you would be contributing valuable knowledge that could help develop new treatments for weight management and diabetes in the future. Potential risks could include unexpected side effects from the new drug, or discomfort from assessments like blood draws. You will be closely monitored, and you have the right to withdraw from the study 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
Netherlands

Common questions

What is RO7795081?

It's a new medicine being tested. It's taken by mouth and is being looked at for its potential to help with weight and diabetes.

Why are only men being included?

Early studies often focus on a specific group to understand the drug's effects more clearly before expanding to others. This study is specifically looking at how healthy men's bodies deal with the drug.

Will this drug help me with my weight or diabetes now?

No, not directly. This is a very early study in healthy people, so it's not designed to treat weight or diabetes at this stage. It's about understanding how the drug works in the body.

What does 'Phase I' mean?

'Phase I' means it's one of the first times this new drug is being tested in humans. The main goal is to check its safety and how the body handles it.

Will I get paid to take part?

Payment for participation in clinical trials can vary significantly. You should ask the study team directly if any reimbursement or compensation is offered for your time and travel.