RecruitingPHASE1INTERVENTIONAL

A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)

This study is testing a new medicine called LY3938577. We want to understand how it behaves in the body, such as how much gets into the bloodstream and how quickly it leaves. We'll also compare its ability to lower blood sugar and how long it lasts against current insulin treatments like Insulin Degludec. Importantly, we'll be carefully checking for any side effects and making sure the medicine is safe. The study involves both healthy volunteers and people with type 1 diabetes, and it's divided into different parts to test the medicine in various ways, including as a single dose or daily treatment, and given by injection or through a drip.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

118

Start

15 May 2024

Estimated completion

01 Sep 2026

Healthy Type 1 Diabetes Mellitus

What is this study about?

This study is looking into a new medicine called LY3938577, which could potentially help people with type 1 diabetes. The main goal is to understand how this new medicine works in the body. We want to find out how much of the medicine gets into the bloodstream and how long it takes for the body to get rid of it. This information is really important for figuring out the right dose and how often someone might need to take it.

Later in the study, we'll check if LY3938577 can help lower blood sugar levels and how long that effect lasts. We'll compare it directly to Insulin Degludec, which is a common insulin treatment used today. This will help us see if the new medicine is as good as, or even better than, what's currently available. We'll also be very carefully watching for any side effects to make sure the medicine is safe for people to use.

The study involves both healthy volunteers and people who have type 1 diabetes. It's broken down into several stages, testing the medicine in different ways. Some participants will receive the medicine through a drip (IV infusion), while others will get it as an injection just under the skin (subcutaneous). This allows the researchers to gather a lot of information about the medicine's effects and how the body handles it.

Key takeaways

New medicine (LY3938577) being tested for type 1 diabetes.
Aims to understand how the medicine works in the body.
Will compare its effects to existing insulin treatments.
Safety and side effects are being carefully monitored.
Includes both healthy people and those with type 1 diabetes.
Participation involves clinic visits and close medical supervision.

Who may be eligible?

This study is looking for both healthy people and those with type 1 diabetes. For people with type 1 diabetes, you generally need to have had the condition for at least 1 or 2 years, and your HbA1c (a measure of average blood sugar over time) should be between 6% and 8.5%.

There are also some general health checks. Your blood pressure, pulse, and standard blood test results need to be normal, and your body mass index (BMI) should be between 18 and 35. You'll also need easy-to-access veins for blood samples. Certain health conditions or recent severe low blood sugar episodes might mean you can't join.

Participants must be between 18 and 64 years old. Women who can become pregnant are not able to participate.

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 between 18 and 64 years old?
If you have type 1 diabetes, have you had it for at least 1-2 years?
Is your HbA1c usually between 6% and 8.5%?
Do you have good general health, including normal blood pressure?
Are you able to attend clinic visits regularly?
Are you comfortable with blood tests and injections?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you'll have several visits to the clinic over a period that could be up to 13 weeks, depending on which part of the study you join. During these visits, you might receive the study medicine, LY3938577, or a different treatment like a placebo (a dummy medicine) or existing insulin. The medicine will be given either through a drip into your arm or as an injection under your skin.

You'll have regular checks by the study team, including blood tests to see how the medicine is working and to monitor your general health. You'll also be closely watched for any side effects. For some parts of the study, you might need to adjust your usual insulin doses under medical guidance, or take part in an exercise test. The research team will explain exactly what's involved in your specific part of the study, including the number of visits and any overnight stays.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to medical knowledge that could lead to new treatments for type 1 diabetes. You'll also receive close medical attention and monitoring. However, there are potential risks, including side effects from the study medicine or other treatments, discomfort from injections or blood tests, or changes to your blood sugar levels. You will be monitored very closely for any issues that arise. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Profil Institut für Stoffwechselforschung
Verified postcode
Neuss, Germany· Recruiting

Common questions

What is LY3938577?

It's a new medicine being tested to see if it can help people with type 1 diabetes manage their blood sugar.

Will I have to stop my current insulin if I join?

Depending on the part of the study, your insulin might be adjusted or monitored, but the medical team will guide this carefully.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers understand the true effects of the new medicine.

How long will the study last for me?

The maximum time you'd be in the study, including screening, is up to around 10 to 13 weeks, depending on which particular part you're in.

Will I know if I'm getting the new medicine or a placebo?

Often in these types of studies, participants don't know which treatment they are receiving until after the study is over, to keep the results fair.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

lillytrials@lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.