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A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

RECRUITINGPhase 3Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 3
SponsorEli Lilly and Company
Started2026-02-05
Est. completion2028-07
Eligibility
Age1 Year – 35 Years
Healthy vol.Accepted
Locations5 sites

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

Age: 1 Year – 35 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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
* Weigh at least 8 kilograms (kg) (18 pounds) at screening

Exclusion Criteria:

* 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

Conditions2

DiabetesDiabetes Mellitus, Type 1

Interventions1

Locations5 sites

Colorado

1 site
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
303-724-3861

Florida

1 site
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308
850-431-5404

Pennsylvania

1 site
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
267-426-7037

Texas

1 site
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
361-739-7250

Virginia

1 site
University of Virginia
Charlottesville, Virginia, 22903
434-924-5956

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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