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

Lilly

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Baricitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07222332

2025-522170-36-00 (EU Trial (CTIS) Number)

27405

I4V-MC-JAJK (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 to 35 years old

Volunteers: No Healthy Volunteers

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, 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 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