Baricitinib to delay the start of clinical (Stage 3) type 1 diabetes in at‑risk children and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, placebo‑controlled trial gives at‑risk participants either baricitinib or matching placebo and follows them for up to about five years to see if treatment delays progression to clinical (Stage 3) type 1 diabetes. Eligible participants have Stage 1b or Stage 2 disease with at least two diabetes‑related autoantibodies and weigh at least 8 kilograms. Key exclusions include other types of diabetes, uncontrolled high blood pressure, recent serious infections, cardiovascular events or heart failure, and a history or high risk of venous thromboembolism, lymphoproliferative disease, or malignancy. Study visits occur at several U.S. sites for regular monitoring, laboratory testing, and safety assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• Tallahassee Memorial HealthCare
  Tallahassee, Florida, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting
• Iowa Diabetes and Endocrinology Research Center
  West Des Moines, Iowa, United States Recruiting
• Novak Center for Children's Health
  Louisville, Kentucky, United States Recruiting
• University of Virginia
  Charlottesville, Virginia, United States Recruiting
• Women's and Children's Hospital
  Adelaide, Australia Recruiting

+62 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.