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

RECRUITINGPhase 3Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 3
SponsorEli Lilly and Company
Started2026-01-12
Est. completion2031-07
Eligibility
Age1 Year – 35 Years
Healthy vol.Accepted
Locations7 sites

Summary

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.

Eligibility

Age: 1 Year – 35 YearsHealthy volunteers accepted
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

Conditions2

DiabetesDiabetes Mellitus, Type 1

Locations7 sites

Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308
850-431-5404
University of South Florida
Tampa, Florida, 33612
813-821-8011
University of Iowa
Iowa City, Iowa, 52242
319-356-4511
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
515-329-6800
Novak Center for Children's Health
Louisville, Kentucky, 40202
502-629-5820

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