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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years

Who can join

Ages 1 to 35 · All sexes

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.

What is being tested

• Baricitinib (drug)
• Placebo (drug)

Sponsor: Eli Lilly and Company · Participants: 150 · Started: Jan 12, 2026

Contact the study team

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559

Official record on ClinicalTrials.gov — NCT07222137

Locations in the U.S.

Conditions

• Type 1 Diabetes

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.