Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study investigating the effect of different approved medications on how the body processes the study compound RO7795081. RO7795081 is a new compound that may potentially be used in the treatment of type 2 diabetes and weight control.

This research study is about a new medicine, RO7795081, which might help people with type 2 diabetes and weight management. We want to understand how your body deals with this new medicine when it's taken alongside other medicines that are already approved and widely used. This is an early-stage study, meaning we're mainly looking at how the medicine works in the body, rather than how well it treats the conditions. By studying this, we can learn more about how RO7795081 interacts with other common medications, which is a vital step in developing new treatments safely and effectively for future patients in the UK.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

08 Nov 2024

Type 2 Diabetes and obesity

What is this study about?

This study is investigating a new medication called RO7795081. Scientists are looking into whether this new drug could potentially be used to help people manage type 2 diabetes and control their weight. Type 2 diabetes is a common condition where the body doesn't produce enough insulin or the insulin it produces doesn't work properly, leading to high blood sugar levels. Obesity means having a lot of excess body fat, which can lead to various health problems.

The main aim of this particular study is to understand how your body processes RO7795081 when it's taken at the same time as other medicines that are already commonly approved and prescribed. Essentially, we want to see if taking RO7795081 with other drugs changes how your body absorbs, uses, or gets rid of it. This is a very important step in developing any new medication.

Learning how different medicines interact is crucial for making sure future treatments are safe and effective. By taking part, you would be helping researchers gather vital information that could shape the development of new ways to treat type 2 diabetes and help with weight management in the future.

Key takeaways

This study is for a new potential medicine for type 2 diabetes and weight control.
It aims to understand how your body processes the new medicine when taken with other drugs.
Participation involves taking the study medicine and having regular health checks and blood tests.
It's an early-stage study, focused on understanding the medicine's behaviour in the body.
Adults aged 18 and over, both men and women, are eligible to participate.

Who may be eligible?

This study is looking for volunteers who are adults, aged 18 years or older. There is no upper age limit for taking part.

Both men and women are welcome to participate in this research. The study does not specify any other particular health conditions or requirements at this early stage, beyond being an adult.

If you're interested, the research team will ask you some questions and carry out a health check to make sure the study is a safe and suitable option 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 able to attend appointments at a research clinic?
Are you willing to take a new study medication?
Are you willing to have blood and urine tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the new study medicine, RO7795081, sometimes on its own and sometimes alongside other approved medications. This will likely involve several visits to a research clinic, where doctors and nurses will monitor your health closely.

During these visits, you might have blood samples taken to see how the study medicine is working in your body, and your vital signs (like blood pressure and heart rate) will be checked regularly. You may also be asked to provide urine samples. The total length of your participation, including any follow-up appointments, will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in any study involves some potential benefits and risks. While there is no guarantee of direct personal benefit, your participation will provide valuable information that could help develop new treatments for type 2 diabetes and weight management in the future. Potential risks might include side effects from the study medication or the approved medications it's co-administered with, or discomfort from blood tests. All known potential risks will be fully explained before you agree to participate, and 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.

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Unverified
Netherlands

Common questions

What is RO7795081?

It's a new medicine being studied that might help with type 2 diabetes and weight control, but it's not approved for use yet.

What does 'Human Pharmacology (Phase I)' mean?

It means this is one of the first studies in people. We're mainly looking at how the body handles the medicine and checking for safety, rather than how well it treats a condition.

Will this study help my diabetes or weight directly?

This early study is mostly about understanding the new medicine. It's not designed to treat your condition directly, but your involvement helps future patients.

What kind of tests will I have?

You can expect regular health checks, blood tests, and possibly urine samples to see how the medicine is working in your body.

Can I stop participating at any time?

Yes, you have the right to withdraw from the study at any point, and it won't affect your regular medical care.