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A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

Who can join

Ages 1 to 35 · All sexes

Inclusion Criteria:

* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
* Have at least one diabetes-related autoantibody found at screening
* Show signs of remaining beta-cell function

  * stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening
* Weigh at least 8 kilograms (kg) (18 pounds) at screening

Exclusion Criteria:

* Have any other type of diabetes including gestational
* 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 medical condition or infection

About the study

The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.

What is being tested

• Baricitinib (drug)
• Placebo (drug)

Sponsor: Eli Lilly and Company · Participants: 300 · Started: Feb 5, 2026

Contact the study team

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

Official record on ClinicalTrials.gov — NCT07222332

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.