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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
View on ClinicalTrials.gov →
NCT07222137
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
Interventions1
Locations7 sites
University of Iowa
Iowa City, Iowa, 52242
319-356-4511
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
515-329-6800
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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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Actively Recruiting
PhasePhase 3
SponsorEli Lilly and Company
Started2026-01-12
Est. completion2031-07
Eligibility
Age1 Year – 35 Years
Healthy vol.Accepted
Locations7 sites
View on ClinicalTrials.gov →
NCT07222137