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

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Baricitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07222137

I4V-MC-JAJJ (Other Identifier)

27404

2025-521797-34-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Baricitinib

Experimental group

Description:

Participants will receive baricitinib orally

Treatment:

Drug: Baricitinib

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo