RecruitingPhase 3NCT07222137
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
Sponsor
Eli Lilly and Company
Enrollment
150 participants
Start Date
Jan 12, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 1 YearMax Age: 35 Years
Inclusion Criteria3
- 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 Criteria5
- 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
Interventions
DRUGBaricitinib
Administered orally
DRUGPlacebo
Administered orally
Locations(108)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07222137
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