Home › Trials › NCT07222332

Baricitinib to preserve insulin-producing beta cells in people newly diagnosed with type 1 diabetes

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

Phase 3 Interventional Eli Lilly and Company · NCT07222332

This trial will test whether the drug baricitinib can help preserve insulin-producing beta cells in children and adults who were recently diagnosed with type 1 diabetes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages1 Year to 35 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsbaricitinib
Locations132 sites (Aurora, Colorado and 131 other locations)
Trial IDNCT07222332 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study randomizes participants to receive baricitinib or placebo and follows them for about 60 weeks. The main outcome is preservation of beta-cell function, measured by stimulated C‑peptide levels. Eligible participants are children and adults diagnosed with type 1 diabetes within the past 100 days, have at least one diabetes-related autoantibody, and meet a minimum C‑peptide threshold at screening. Major exclusions include other diabetes types, significant cardiovascular disease, high risk of venous thromboembolism, recent serious infection, or malignancy.

Who should consider this trial

Good fit: Children and adults diagnosed with type 1 diabetes within the past 100 days who have at least one diabetes autoantibody and a stimulated C‑peptide ≥0.2 nmol/L are ideal candidates.

Not a fit: People with other forms of diabetes, very low or absent C‑peptide, uncontrolled cardiovascular disease, a history or high risk of blood clots or malignancy, or recent serious infections are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, baricitinib could slow loss of insulin-producing cells, lower insulin needs, and improve blood sugar control for people with new-onset type 1 diabetes.

How similar studies have performed: Using JAK inhibitors like baricitinib in type 1 diabetes is relatively novel: preclinical and early-phase work have suggested potential but large-scale phase 3 evidence in new-onset T1D is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* 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

Where this trial is running

Aurora, Colorado and 131 other locations

+82 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 1T1DMChildrenNew-onsetBeta-cell Function
Last reviewed 2026-06-13 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.