AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Study to Evaluate the Effect of RO7204239 on Insulin Sensitivity and Muscle Composition in Participants with Type 2 Diabetes Mellitus(T2DM) and Overweight or Obesity

This research study is testing a new medicine, known for now as RO7204239. The main goal is to understand how this medication might affect two important things in your body: firstly, how well your body uses insulin (often called ‘insulin sensitivity’), and secondly, the composition of your muscles. This study is specifically for adults who have been diagnosed with type 2 diabetes and are also considered overweight or obese. It's an early-stage study, meaning researchers are mainly checking if the medicine is safe and how it works in the body.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

15 Aug 2025

Type 2 Diabetes Mellitus (T2DM) and overweight or obesity

What is this study about?

This study is focused on a new medicine called RO7204239. Doctors and scientists want to understand two key things about this medicine in people with type 2 diabetes who are also overweight or obese. The first is how it affects ‘insulin sensitivity’. Insulin is a hormone that helps your body use sugar for energy. If you have type 2 diabetes, your body might not use insulin as well as it should, or it might not make enough. Improving insulin sensitivity means your body gets better at using the insulin it has.

The second area of focus is how the medicine affects ‘muscle composition’. This refers to the different parts that make up your muscles. Our muscles play a big role in how our body uses energy and processes sugar. By looking at these two areas, researchers hope to learn if this new medicine could be a helpful way to manage type 2 diabetes and related health concerns.

This is an early phase of research, sometimes called a ‘Human Pharmacology’ or ‘Phase I’ study. This means it's one of the first times this medicine is being given to people. The main goals at this stage are usually to check if the medicine is safe, to understand how it behaves in the body, and to figure out what dose might be most effective. It's not yet about proving it's better than existing treatments, but about gathering fundamental information.

Key takeaways

This study is testing a new medicine for type 2 diabetes.
It aims to see how the medicine affects insulin use and muscles.
It's for adults with type 2 diabetes who are also overweight or obese.
This is an early-stage study to check safety and how the medicine works.
Taking part means regular visits and close medical monitoring.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, so older adults can also take part.

Participants must have a diagnosis of type 2 diabetes. You also need to be classified as overweight or obese, which doctors usually determine based on your weight and height.

Both men and women are welcome to participate in this study. The research team will review all your medical information to make sure the study is a good fit for you and that you meet all the specific health requirements.

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?
Do you have a diagnosis of type 2 diabetes?
Are you considered overweight or obese?
Are you able to attend regular clinic visits?
Are you willing to potentially receive an experimental medicine?

Answer every question to see your result.

What does participation involve?

The detailed plan for what taking part involves hasn't been shared yet. However, in an early-stage study like this, you would typically have a number of visits to a clinic or hospital. These visits would likely involve various assessments, such as blood tests, physical examinations, and potentially tests to measure your insulin sensitivity and muscle composition. You would be given the study medicine, RO7204239, according to a specific schedule, and you would be carefully monitored for any effects. There would also be follow-up appointments to check on your health after you've finished taking the medicine. The total duration of your participation in the study, from your first visit to your last follow-up, would be explained to you in detail.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving close medical attention and access to a new experimental medicine before it's widely available. However, there are also potential risks involved, including possible side effects from the study medicine, which are not yet fully known. As with any clinical trial, 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
Germany

Common questions

What is insulin sensitivity?

Insulin sensitivity means how well your body's cells respond to insulin. When it's good, your body uses insulin effectively to manage blood sugar.

What is 'muscle composition'?

Muscle composition refers to what your muscles are made of, for example, the balance of fat versus lean muscle tissue.

Is this medicine available to the public?

No, RO7204239 is an experimental medicine and is not currently available outside of this research study.

What does 'Phase I' mean for a study?

Phase I means it's an early study to check if a new medicine is safe and how it works in the body, before large-scale testing.

Will I know if I'm getting the actual medicine?

Sometimes in studies, people might get the active medicine or a placebo (a dummy medicine). The researchers will explain this to you fully.