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A Study of Baricitinib for Delaying Type 1 Diabetes

This study is investigating if an oral medication called baricitinib (LY3009104) can delay the development of full-blown (Stage 3) type 1 diabetes in children and adults. You might be eligible if you are between 1 and 35 years old, weigh at least 18 pounds, and have Stage 1b or Stage 2 type 1 diabetes, which means your body is already showing signs of attacking insulin-producing cells (detected by specific autoantibodies). The main goal is to see how long it takes for participants to be diagnosed with Stage 3 type 1 diabetes. This study plans to enroll 150 participants, and the current recruitment status is unclear.

Study design
This interventional study will compare baricitinib to a placebo (an inactive pill) in about 150 participants. The study is designed to see if baricitinib can delay the onset of Stage 3 type 1 diabetes.
What's involved
Participation in this study will last for up to approximately 5 years. You will take either baricitinib or a placebo orally.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study up to approximately 5 years to measure the time until diagnosis of Stage 3 type 1 diabetes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222137

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

Recruiting
PHASE3Ages 1–35InterventionalTreatment
Eli Lilly and Company
~150 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:BaricitinibPlacebo

At a glance

Recruiting sites
83 of 113 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Measured over Baseline up to approximately 5 years

Conditions

Diabetes Mellitus, Type 1

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

113 sites across 24 states
Israel13
Brazil10
Italy10
United Kingdom10
Australia9
France9
Japan9
Belgium5

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening
Have Stage 1b or Stage 2 type 1 diabetes
Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening

Exclusion

Have any other type of diabetes
Have uncontrolled high blood pressure
Have had a heart attack, heart disease, stroke, or heart failure
Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy
Have a current or recent clinically serious infection

What this trial measures

  • Time from Baseline to Diagnosis of Stage 3 Type 1 DiabetesBaseline up to approximately 5 years