A Study of Baricitinib for Newly Diagnosed Type 1 Diabetes

This study is testing whether a drug called baricitinib can help preserve the body's ability to make insulin (beta-cell function) in children and adults who have been recently diagnosed with type 1 diabetes. Participants will receive either baricitinib or a placebo (an inactive substance) orally. We're looking to see if there's a change in C-peptide (a measure of insulin production) after 52 weeks. You may be able to join if you are between 1 and 35 years old, were diagnosed with type 1 diabetes within the last 100 days, have certain diabetes-related autoantibodies, and show signs of remaining beta-cell function. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This interventional study will involve about 300 participants. It compares baricitinib to a placebo, both given orally.
What's involved
Participation in the study will last about 60 weeks. Your C-peptide levels will be measured at the beginning and again at Week 52.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring C-peptide change is at Week 52.

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NCT07222332

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

Recruiting
PHASE3Ages 1–35InterventionalTreatment
Eli Lilly and Company
~300 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BaricitinibPlacebo

At a glance

Recruiting sites
99 of 138 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in C-peptide Area Under the Curve (AUC)
Measured over Baseline, Week 52
Diabetes Mellitus, Type 1
138 sites across 24 states
Brazil15
Israel11
Australia10
Italy10
Belgium9
France9
Spain9
Germany8
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Change from Baseline in C-peptide Area Under the Curve (AUC)Baseline, Week 52