Active not recruitingPHASE1INTERVENTIONAL

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 important study is investigating a new medication called RO7204239. It's designed for people living with type 2 diabetes who are also overweight or have obesity. The main goal is to find out if this new drug can help the body use insulin more effectively, a process known as improving 'insulin sensitivity'. Researchers will also be looking at how the drug might affect muscle health. As a 'Phase 1' study, it's an early step in testing the drug, often focusing on safety and how the body handles the new medicine, comparing it to a dummy treatment (placebo). This research is crucial for potentially developing new ways to manage type 2 diabetes and its related health challenges.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Hoffmann-La Roche

Enrolment target

Start

30 Sep 2025

Estimated completion

28 Feb 2027

Type 2 Diabetes Mellitus Obesity Overweight

What is this study about?

This research study is looking into a new medication called RO7204239. It's designed for adults who have type 2 diabetes and are also overweight or have obesity. The main thing the researchers want to understand is how this new drug affects 'insulin sensitivity'. In simple terms, insulin sensitivity refers to how well your body's cells respond to insulin, a hormone that helps your body use sugar for energy. In type 2 diabetes, the body often doesn't use insulin effectively.

The study also aims to look at how RO7204239 might affect muscle composition, which means the make-up of your muscles. By improving insulin sensitivity, the hope is that this new drug could offer a different way to help manage type 2 diabetes. This study will compare the new drug against a placebo, which is a dummy treatment with no active medicine, to see if RO7204239 has a noticeable effect.

This is an early-stage study, known as Phase 1. This means it's one of the first times the drug is being tested in humans. The focus at this stage is often on understanding if the drug is safe and how the body processes it. Finding new treatments is vital for people with type 2 diabetes to help control blood sugar levels and improve overall health.

Key takeaways

Investigating a new drug (RO7204239) for type 2 diabetes.
Focuses on improving how the body uses insulin, and muscle health.
Compares the drug to a dummy treatment (placebo).
It's an early-stage study (Phase 1) looking at safety and how the body handles the drug.
Open to adults with type 2 diabetes who are overweight or have obesity.
Participation involves regular clinic visits and health checks.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older, and have type 2 diabetes for at least six months. Your diabetes should be managed with diet, exercise, or certain common diabetes medications like metformin, or a combination of these. Your blood sugar control, measured by something called HbA1c, needs to be within a specific range, even if you're on medication. Your weight also plays a part, with a body mass index (BMI) between 27 and 45 kg/m2, and your weight should have been stable for three months before the study starts. If you take medication for cholesterol or high blood pressure, those doses also need to have been stable for at least three months.

There are also some reasons why you might not be able to join. For example, if you have type 1 diabetes, or have had certain serious diabetes-related emergencies in the last six months, such as diabetic ketoacidosis. Other reasons include certain serious eye conditions related to diabetes, uncontrolled existing health problems like very high blood pressure or cholesterol, or if you've had severe low blood sugar episodes recently. You'd also be excluded if you have certain nerve problems caused by diabetes, other uncontrolled hormone problems, or if you're taking specific stimulant medications. Having allergies to the study drug or placebo, or recent significant blood loss or donation, would also prevent participation.

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 over?
Do you have type 2 diabetes that has been managed for at least 6 months?
Is your body mass index (BMI) between 27 and 45?
Has your weight been stable for the last 3 months?
Have you *not* had serious diabetes-related emergencies recently (like diabetic ketoacidosis)?
Are you *not* taking certain stimulant medications?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of a research group that will either receive the new drug RO7204239 or a placebo (a dummy treatment). You won't know which one you're getting, and neither will the study team. You'll have regular visits to the clinic where doctors and nurses will monitor your health closely. This will involve physical examinations, blood tests, and other assessments to check how your body is responding to the treatment and to ensure your safety. The study team will provide you with the medication, and you'll need to follow their instructions carefully about how and when to take it. There will be multiple visits over a period of time, and the total duration of your participation will be explained to you by the study team. You'll also have follow-up appointments to make sure everything is okay after you stop taking the study medication. All travel costs to and from the clinic will be covered, and you may be reimbursed for your time.

Potential risks and benefits

Taking part in a clinical trial could offer some potential benefits. You'll receive regular medical care and close monitoring by a dedicated study team. You might also be among the first to access a new potential treatment that could help improve your insulin sensitivity and overall diabetes management, though there's no guarantee it will work for you. However, there are also potential risks, including side effects from the study drug, which are currently unknown as this is an early-stage study. There's also the chance that the treatment might not be effective for you, or you could receive the placebo. Before you decide, the study team will explain all known and potential risks in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Profil Institut für Stoffwechselforschung
Verified postcode
Homburg, Germany

Common questions

What is insulin sensitivity?

Insulin sensitivity is how well your body's cells react to insulin, a hormone that helps use sugar for energy. If your body is 'insulin sensitive', it means your cells respond well. If not, like in type 2 diabetes, your cells don't respond as well.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers see if the real drug is actually causing any changes, or if the changes are due to other factors.

What does 'Phase 1' mean for a study?

A Phase 1 study is an early stage of testing a new drug in humans. It mostly focuses on whether the drug is safe, how much is safe to use, and how the body handles it. It's a stepping stone before larger studies.

Will I know if I'm getting the drug or the placebo?

No, in this type of study, neither you nor the doctors will know whether you are receiving the active study drug or the placebo. This helps ensure the results are accurate and unbiased.

What is 'HbA1c'?

HbA1c is a blood test that measures your average blood sugar levels over the past two to three months. It's a common way to see how well your diabetes is being managed.