Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to assess the pharmacokinetics, and glucodynamics of LY3209590 in participants with type 2 diabetes

This research study is for people who have type 2 diabetes. The main goal is to learn more about a new medication called LY3209590. Specifically, the doctors and scientists want to see how this medicine moves through your body and how it affects your blood sugar levels. This type of study, often called a Phase 1 study, is usually one of the first steps in testing a new treatment in humans. It's crucial for understanding how safe and effective a new medicine might be before it can be used more widely. By taking part, you would be helping researchers gather vital information that could lead to new ways to manage type 2 diabetes in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Eli Lilly & Co.

Enrolment target

Start

01 Dec 2023

Type 2 Diabetes Mellitus

What is this study about?

This study is about a new medicine called LY3209590, which is being developed to help people with type 2 diabetes. When a new medicine is created, scientists need to understand exactly how it works once it's in the human body. Think of it like learning how a new fuel works in a car – they want to see how quickly it's used up, what effect it has, and if there are any unexpected reactions.

In this particular study, researchers are focusing on two main things. First, they want to understand the 'pharmacokinetics' of LY3209590. This simply means how the medicine is absorbed into your body, where it goes, how your body deals with it, and how it gets removed. Second, they are looking at 'glucodynamics,' which is a fancy word for how the medicine affects your blood sugar levels. Does it lower them? Does it keep them stable? These are important questions for a diabetes medication.

This is an early-stage study, often called a Phase 1 study, which means it's one of the first times this specific medicine is being tested in people. These studies are designed to be very thorough and carefully monitored to ensure safety and to get a good initial idea of how the medicine behaves. The information gathered from studies like this is essential for deciding if the medicine should be tested further in larger groups of people, with the ultimate goal of finding new and better treatments for type 2 diabetes.

Key takeaways

This study is testing a new medicine (LY3209590) for type 2 diabetes.
It aims to understand how the medicine works and affects blood sugar.
It's an early-stage (Phase 1) study, focusing on safety and initial effects.
Adults aged 18 and over, both men and women, with type 2 diabetes may be eligible.
Participation helps advance research for future diabetes treatments.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults aged 18 years and older. There is no upper age limit, meaning older adults can also be considered.

Both men and women are welcome to take part in this research.

Because this is an early-stage study and you have type 2 diabetes, the healthcare team will need to check your general health very carefully to make sure it's safe for you to participate. They will review your medical history and current health to confirm if you are a good fit for the study.

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 type 2 diabetes?
Are you able to attend study visits regularly?
Are you generally in good health, apart from your diabetes?
Are you willing to follow specific study instructions?

Answer every question to see your result.

What does participation involve?

The specific details of what taking part involves aren't fully described, but in an early-stage study like this, you would generally expect several visits to the study clinic. These visits might include physical examinations, blood tests to check how the medicine is working and its effects on your body, and possibly heart scans. You would receive the study medication, LY3209590, likely through injections or tablets, and may need to have your blood sugar levels monitored closely. There will be careful follow-up after you take the medication. The total duration of your participation would be explained to you in detail if you were considering joining.

Potential risks and benefits

Participating in research studies can have potential benefits, such as gaining access to a new experimental medicine before it's widely available, and closely monitored medical care. You would also be helping advance medical knowledge for type 2 diabetes. However, there are also potential risks, including side effects from the new medicine, which are not fully known yet, or discomfort from study procedures like blood tests. You will be given a document that explains all known risks. Remember, you have the right 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.

—
Unverified
Germany

Common questions

What is LY3209590?

It's a new, experimental medicine being tested for people with type 2 diabetes. Researchers are trying to understand how it works.

Why is this study being done?

The goal is to find out how the new medicine LY3209590 behaves in the body and how it affects blood sugar levels in people with type 2 diabetes.

Is this a new type of treatment?

Yes, it's a new medicine currently in the early stages of testing. It's not yet available outside of clinical trials.

Will I get paid to participate?

Payment for participation varies between studies. This information would be fully explained to you before you agree to join if you are eligible.

What does 'Phase 1' study mean?

It means this is one of the first times the new medicine is being tested in humans. These studies focus on safety and how the medicine works in the body.