Status:
NOT_YET_RECRUITING
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
1-35 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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, or
- random C-peptide result \>0.3 nmol/L (0.9 ng/mL) during the screening period
- Weigh at least 8 kilograms (kg) (18 pounds) at screening
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07222332
Start Date
March 1 2026
End Date
July 1 2028
Last Update
December 17 2025
Active Locations (129)
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1
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
2
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104
3
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
4
University of Virginia
Charlottesville, Virginia, United States, 22903