RecruitingPhase 3NCT07222332
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
Sponsor
Eli Lilly and Company
Enrollment
300 participants
Start Date
Feb 5, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 1 YearMax Age: 35 Years
Inclusion Criteria6
- 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 Criteria5
- 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
Interventions
DRUGBaricitinib
Administered orally
DRUGPlacebo
Administered orally
Locations(129)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07222332
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