RecruitingPHASE2INTERVENTIONAL

A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

This study is investigating a new medication called LY3457263 for individuals living with Type 2 Diabetes. The aim is to see if LY3457263 can help lower blood sugar levels (measured by HbA1c) in people who are already taking established diabetes medications such as semaglutide or tirzepatide, but whose blood sugar levels are still not ideally controlled. Researchers will compare LY3457263 with a placebo (a dummy treatment with no active drug) to understand its effects. The study involves volunteers who will participate for approximately 9 months. This research is in Phase 2, meaning it's an earlier stage of testing to see if the drug is safe and effective.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

240

Start

28 Mar 2025

Estimated completion

01 Jan 2027

Type 2 Diabetes

What is this study about?

This study is focused on people who have Type 2 Diabetes. We know that managing blood sugar levels is a really important part of living with diabetes, and for some people, even with current medications, their blood sugar might still be a bit too high. This study is testing a new medication, called LY3457263, to see if it can help improve blood sugar control for these individuals.

The main goal is to find out if LY3457263 can help lower a measure called HbA1c. HbA1c gives an overall picture of average blood sugar levels over the past few months. The study will compare LY3457263 to a 'placebo', which is a dummy treatment that looks just like the real medicine but contains no active drug. This comparison helps researchers understand if any changes are truly due to the new medication or other factors.

This research is in what's known as 'Phase 2'. This means it's an earlier stage of testing where scientists are primarily looking at whether the new drug is safe and effective in a smaller group of people. The information gathered from this study will help decide if LY3457263 should be studied further in larger trials.

Key takeaways

This study is for people with Type 2 Diabetes whose blood sugar is still high on current treatments.
It tests a new medication, LY3457263, against a dummy treatment (placebo).
The main goal is to see if the new drug can lower average blood sugar levels (HbA1c).
Participants will be in the study for about 9 months.
You must already be on stable doses of semaglutide or tirzepatide to be considered.
This is an early-stage study (Phase 2) to check safety and effectiveness.

Who may be eligible?

To be considered for this study, you would need to have Type 2 Diabetes and your blood sugar levels (measured by HbA1c) should be a bit elevated, specifically between 7.5% and 10.5%. You should also have a body mass index (BMI) of 27 or higher, and your weight should have been stable for at least three months before joining. Importantly, you must have been taking a stable dose of either injectable semaglutide or injectable tirzepatide 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 a history of certain serious diabetes complications like ketoacidosis, you wouldn't be eligible. Also, if you've had certain heart or brain conditions (like a heart attack or stroke) in the last three months, or if you've used insulin recently (unless it was for a very short period), you wouldn't be able to participate. The study also has rules about other diabetes medicines you might be taking and whether you've used weight loss medications recently.

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.

I have Type 2 Diabetes.
My recent HbA1c was between 7.5% and 10.5%.
My BMI is 27 or higher.
I have been taking a stable dose of injectable semaglutide or tirzepatide for at least 3 months.
I have not had a heart attack or stroke in the last 3 months.
I have not used insulin in the last year (excluding very short-term use).

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would last for about 9 months. During this time, you would receive either the new study medication (LY3457263) or a placebo. You would continue to take your existing semaglutide or tirzepatide as prescribed. You would have regular visits to the clinic for various assessments, including blood tests to check your HbA1c and other health markers, and to monitor your general health. You would be given instructions on how to take the study medication. After your last dose of the study medication, there would be a follow-up period to ensure your health is monitored.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit could be that the new medication, LY3457263, might help improve your blood sugar control. While the new drug is being tested, potential risks include experiencing side effects, some of which may be unknown. There's also a chance you might receive the placebo, meaning you wouldn't get the active study drug. You would be closely monitored throughout the study, and your doctors would discuss any potential risks in detail. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (60)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Helios Clinical Research - Phoenix
Verified postcode
Phoenix, United States· Recruiting
Wolverine Clinical Trials
Verified postcode
Santa Ana, United States· Recruiting
Renstar Medical Research
Verified postcode
Ocala, United States· Recruiting
Oviedo Medical Research
Verified postcode
Oviedo, United States· Recruiting
Balanced Life Health Care Solutions/SKYCRNG
Verified postcode
Lawrenceville, United States· Recruiting
Physicians Research Associates
Verified postcode
Lawrenceville, United States· Not yet recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Verified postcode
Union City, United States· Recruiting
North Georgia Clinical Research
Verified postcode
Woodstock, United States· Recruiting
Elite Clinical Trials
Verified postcode
Rexburg, United States· Recruiting
Investigators Research Group
Verified postcode
Brownsburg, United States· Recruiting
Clinical Research of Philadelphia
Verified postcode
Pennington, United States· Not yet recruiting
NYC Research INC
Verified postcode
Long Island City, United States· Recruiting

Common questions

What is Type 2 Diabetes?

Type 2 Diabetes is a common condition where the body doesn’t make enough insulin or the insulin it makes doesn’t work properly, leading to high blood sugar levels. It's often managed with lifestyle changes and medication.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months. It's a key measure for how well diabetes is being managed.

What is a placebo?

A placebo is a substance or treatment that looks exactly like the real medication but doesn't contain any active drug. It's used to compare against the new medicine to see its true effects.

What does 'Phase 2' mean for a clinical trial?

Phase 2 means that this is an earlier stage of testing for a new drug. Researchers are looking into whether the drug is safe and if it shows promise in treating the condition, usually in a smaller group of people.

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

Clinical trials are often 'blinded,' meaning neither you nor your study doctor would know whether you are receiving the new drug or the placebo. This helps prevent bias in the results.

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.