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A Study of Baricitinib to Delay Type 1 Diabetes in Children and Adults at Risk of Developing the Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people who are at risk of developing Type 1 Diabetes. Type 1 Diabetes is a condition where the body's immune system attacks the cells in the pancreas that make insulin, a hormone needed to control blood sugar levels. People in this study have certain markers in their blood called autoantibodies that show they are at increased risk of developing this condition. The study will test a medication called baricitinib, also known by its code name LY3009104, which will be given as tablets or as a liquid suspension that can be swallowed. Some participants will receive baricitinib while others will receive placebo.

The purpose of this study is to see if baricitinib can delay or prevent the progression to Stage 3 Type 1 Diabetes in people who are at risk. Stage 3 is when symptoms of diabetes appear and blood sugar levels become difficult to control. The study aims to find out if baricitinib works better than placebo in keeping people from reaching this stage of the disease.

During the study, participants will take either baricitinib or placebo by mouth for up to 60 months. Throughout this time, they will be monitored to see if and when they develop Stage 3 Type 1 Diabetes. The study will track how long it takes from the beginning of treatment until a diagnosis of Stage 3 Type 1 Diabetes occurs. The entire study is expected to last several years to gather enough information about whether the treatment can successfully delay the disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    Upon joining the study, you will be randomly assigned to receive either baricitinib or placebo. A placebo is an inactive substance that looks like the actual medication but contains no active ingredient.

    This is a double-blind study, which means neither you nor your doctor will know whether you are receiving baricitinib or placebo during the treatment period.

    The medication will be administered by oral use, meaning you will take it by mouth.

  2. Step 2

    Taking the study medication

    You will take the assigned medication regularly throughout the study period.

    The medication is available as an oral suspension, which is a liquid form that can be swallowed.

    You will need to follow the dosing schedule provided by the study team.

  3. Step 3

    Regular monitoring visits

    Throughout the study, you will attend regular monitoring appointments.

    During these visits, you will be checked for signs of Stage 3 type 1 diabetes. Stage 3 type 1 diabetes refers to the point when blood sugar levels become high enough to cause noticeable symptoms and meet diagnostic criteria for diabetes.

    The study team will monitor your condition to see if and when Stage 3 type 1 diabetes develops.

  4. Step 4

    Study duration

    The study will continue for up to approximately 5 years.

    You will remain in the study and continue taking the assigned medication unless Stage 3 type 1 diabetes is diagnosed or until the study ends.

    The estimated completion date for the entire study is May 2031.

Who can join the trial?

3 criteria

  • You must have at least two diabetes-related autoantibodies in your medical history. Autoantibodies are proteins made by your immune system that mistakenly attack your own body. You must also have two diabetes-related autoantibodies confirmed at the screening visit or before screening.
  • You must be at risk for type 1 diabetes, specifically having Stage 1b or Stage 2. This means you have early signs that your body is developing type 1 diabetes, but you do not yet have the full disease.
  • You must weigh at least 8 kilograms, which is about 18 pounds, at the screening visit.

Who cannot join the trial?

14 criteria

  • You have Stage 3 type 1 diabetes, which means you already have clear symptoms of diabetes and need insulin treatment
  • You are taking medicines that affect your immune system, which is the body's natural defense system against illness
  • You have a history of blood clots, which are blockages in blood vessels that can be dangerous
  • You have serious infections that are active or keep coming back
  • You have liver disease or problems with how your liver works
  • You have kidney disease or your kidneys are not working properly
  • You have cancer or had cancer in the past few years, except for certain skin cancers that were successfully treated
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have received live vaccines recently, which are vaccines made from weakened germs
  • You have tuberculosis, which is a serious lung infection, or have been exposed to it without proper treatment
  • You have hepatitis B or C, which are viral infections affecting the liver
  • You have low levels of certain blood cells that help fight infection or help blood clot
  • You are allergic to the study medicine or any of its ingredients
  • You have other serious medical conditions that could make it unsafe for you to participate
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Investigated drugs

  • Baricitinib

    is a medication that affects the immune system. In this study, it is being tested to see if it can delay or prevent the development of Stage 3 type 1 diabetes in people who are at risk of getting this disease. The medication works by blocking certain signals in the body that are involved in the immune response, which may help protect the cells in the pancreas that make insulin.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against baricitinib to see if baricitinib actually works better than no treatment at all.

What is already known about the treatment

Baricitinib – Baricitinib is a medication that comes in tablet form and is taken by mouth, usually once daily with or without food. It is an approved drug that works by blocking certain proteins in the body called JAK enzymes, which are involved in the immune system's inflammatory response. In this clinical trial, baricitinib is being studied as a potential treatment to delay or prevent the development of Type 1 Diabetes in people who are at high risk of developing this condition, though this use is still experimental and under investigation.

Investigated diseases

Type 1 Diabetes Mellitus – Type 1 Diabetes Mellitus is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow sugar to enter cells to produce energy. The disease occurs when the body's immune system mistakenly attacks and destroys the insulin-producing cells in the pancreas. This condition typically develops in children and young adults, although it can appear at any age. Without insulin, sugar builds up in the bloodstream instead of being used by cells. People with this disease must regularly monitor their blood sugar levels and require insulin replacement throughout their lives. The progression can occur in stages, with Stage 3 being when symptoms become apparent and insulin therapy becomes necessary.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521797-34-00Protocol codeI4V-MC-JAJJEstimated enrolment155 patientsSponsorEli Lilly & Co.

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