RecruitingPHASE3INTERVENTIONAL

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

This research trial is investigating a medicine called baricitinib (also known as LY3009104) to see if it can help delay the start of Type 1 Diabetes in children and adults. We're looking for people aged 1 to 35 years old who are considered to be at a high risk of developing the condition, but haven't been diagnosed with it yet. The study will compare baricitinib with a dummy medicine (placebo) over a period of up to five years. The main goal is to find out if this treatment can stop or slow down the progression to full Type 1 Diabetes, which could make a big difference for many families.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

150

Start

12 Jan 2026

Estimated completion

01 Jul 2031

Diabetes Mellitus, Type 1

What is this study about?

This study is focused on a health condition called Type 1 Diabetes. Usually, when someone gets Type 1 Diabetes, their body's immune system mistakenly attacks and destroys the cells in the pancreas that produce insulin. Insulin is a hormone essential for turning sugar from food into energy. This study is for people who are considered to be at a high risk of developing Type 1 Diabetes, meaning their immune system has already started showing signs of this attack, but they don't yet have full-blown diabetes.

The aim of this research is to see if a medicine called baricitinib can help delay or even prevent the full onset of Type 1 Diabetes. Baricitinib works by calming down the immune system. By doing this, researchers hope it might protect the insulin-producing cells for longer, allowing people to avoid or push back the need for daily insulin injections.

Finding a way to delay or prevent Type 1 Diabetes would be a huge step forward. It could significantly improve the quality of life for many individuals and families by reducing the burden of managing the condition from a young age.

Key takeaways

New study for delaying Type 1 Diabetes.
Investigates a medicine called baricitinib.
For children and adults (1-35 years) at high risk.
Compares medicine to a dummy pill (placebo).
Study lasts up to 5 years with regular check-ups.
Aims to prevent or slow down Type 1 Diabetes onset.

Who may be eligible?

To join this study, participants need to be between 1 and 35 years old. A key part of qualifying is having specific 'markers' in your blood, called autoantibodies, which show that your immune system is already starting to target the cells that produce insulin. You'd need to have shown these markers at least twice.

We are looking for individuals who are in what is known as 'Stage 1b' or 'Stage 2' Type 1 Diabetes. This means your body is showing signs of the immune system attacking, but you don't yet have the symptoms of full Type 1 Diabetes. Participants must also weigh at least 8 kilograms (about 1 stone 4 pounds).

There are also some reasons why you might not be able to join. For example, if you have any other type of diabetes, or certain other health conditions like uncontrolled high blood pressure, previous serious heart problems (like a heart attack or heart failure), a history of blood clots, or certain types of cancer. Also, if you have a serious infection currently or recently, you wouldn't be able to take part.

Quick self-check

Are you between 1 and 35 years old?
Have you been told you have specific 'autoantibodies' for Type 1 Diabetes?
Do you already have a diagnosis of 'Stage 1b' or 'Stage 2' Type 1 Diabetes?
Do you weigh at least 8 kilograms (about 1 stone 4 pounds)?
Do you have any other type of diabetes?
Have you had serious heart problems or a history of blood clots?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be in the study for up to five years. You'll either receive the study medicine, baricitinib, or a 'dummy' medicine (placebo), given as pills. Neither you nor your study doctor will know which one you are receiving. You'll have regular visits to the clinic for medical check-ups, blood tests, and to assess your general health and how well the treatment is working. These visits will be more frequent at the beginning and then become less frequent over time. The team will carefully monitor your health throughout the study.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing an investigational treatment that might delay Type 1 Diabetes, which isn't currently available outside of research. However, there are potential risks, as with any medicine. Baricitinib may have side effects, and some people may experience no benefit at all. All potential risks will be thoroughly explained to you before you decide to join. Remember, participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (107)

Tallahassee Memorial HealthCare
Tallahassee, United States· Not yet recruiting
University of South Florida
Tampa, United States· Suspended
University of Iowa
Iowa City, United States· Not yet recruiting
Iowa Diabetes and Endocrinology Research Center
West Des Moines, United States· Recruiting
Novak Center for Children's Health
Louisville, United States· Not yet recruiting
Children's Hospital of Philadelphia (CHOP)
Philadelphia, United States· Not yet recruiting
University of Virginia
Charlottesville, United States· Not yet recruiting
Women's and Children's Hospital
Adelaide, Australia· Recruiting
Box Hill Hospital
Box Hill, Australia· Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Australia· Not yet recruiting
Centre for Children's Health Research
Brisbane, Australia· Not yet recruiting
Royal Children's Hospital
Melbourne, Australia· Not yet recruiting

+95 more sites — see the official record for the full list.

Common questions

What exactly is Type 1 Diabetes?

Type 1 Diabetes is a condition where your body's immune system attacks and destroys the cells in your pancreas that make insulin, a hormone needed to use sugar for energy.

What does 'at-risk' mean?

It means you have signs in your blood (specific antibodies) that show your immune system is starting to attack, but you don't yet have the symptoms of Type 1 Diabetes.

Will I get the actual medicine or a dummy pill?

You will receive either baricitinib or a 'dummy' pill (placebo). It's a 'blinded' study, meaning neither you nor your doctors will know which one you're receiving.

How long will the study last?

Your participation in the study could last for up to approximately five years.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your future medical care.

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.