Recruiting

Phase 3

BaricitinibA Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

Sponsor:

Eli Lilly and Company

Code:

NCT07222137

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 1 - 35

Healthy Volunteers: Not accepted

Interventions

Baricitinib

Placebo

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT07222137

Start date

Jan 12, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 35

Healthy Volunteers: Not 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Baricitinib

Participants will receive baricitinib orally

placebo comparator: Placebo

Participants will receive placebo orally

Interventions

Baricitinib

Administered orally

Placebo

Administered orally

Primary outcome measure

Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes [ Time Frame: Baseline up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Tallahassee Memorial HealthCare

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

850-431-5404

Principal Investigator:

Larry Deeb

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

319-356-4511

Principal Investigator:

Michael Tansey

Iowa Diabetes and Endocrinology Research Center

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

515-329-6800

Principal Investigator:

Anuj Bhargava

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

Aaron Misakian

BC Diabetes Office

Recruiting

Vancouver, Canada, V5Y 3W2

Contacts

604-683-3734 x 1001

Principal Investigator:

Thomas Elliott

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.