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Baricitinib to delay the start of clinical (Stage 3) type 1 diabetes in at‑risk children and adults

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years

Phase 3 Interventional Eli Lilly and Company · NCT07222137

This will test whether the medicine baricitinib can delay the start of clinical type 1 diabetes in children and adults who are at high risk.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages1 Year to 35 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsbaricitinib
Locations107 sites (Tallahassee, Florida and 106 other locations)
Trial IDNCT07222137 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo‑controlled trial gives at‑risk participants either baricitinib or matching placebo and follows them for up to about five years to see if treatment delays progression to clinical (Stage 3) type 1 diabetes. Eligible participants have Stage 1b or Stage 2 disease with at least two diabetes‑related autoantibodies and weigh at least 8 kilograms. Key exclusions include other types of diabetes, uncontrolled high blood pressure, recent serious infections, cardiovascular events or heart failure, and a history or high risk of venous thromboembolism, lymphoproliferative disease, or malignancy. Study visits occur at several U.S. sites for regular monitoring, laboratory testing, and safety assessments.

Who should consider this trial

Good fit: Ideal candidates are children or adults with Stage 1b or Stage 2 type 1 diabetes who have at least two diabetes‑related autoantibodies and weigh at least 8 kilograms.

Not a fit: People with other types of diabetes, established clinical (Stage 3) type 1 diabetes, or those with uncontrolled cardiovascular disease, recent serious infections, a high risk of venous thromboembolism, lymphoproliferative disease, or malignancy would not be expected to benefit and are excluded.

Why it matters

Potential benefit: If successful, baricitinib could delay the clinical onset of type 1 diabetes, helping preserve insulin‑producing beta cell function and postponing the need for insulin therapy.

How similar studies have performed: Some immune‑modulating therapies (for example, teplizumab) have shown the ability to delay onset of clinical type 1 diabetes, but using the JAK inhibitor baricitinib for this purpose is relatively novel with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Tallahassee, Florida and 106 other locations

+57 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.