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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Barbara Davis Center for Childhood Diabetes
  Aurora, Colorado, United States Recruiting
• Tallahassee Memorial HealthCare
  Tallahassee, Florida, United States Recruiting
• Driscoll Children's Hospital
  Corpus Christi, Texas, United States Recruiting
• University of Virginia
  Charlottesville, Virginia, United States Recruiting
• Women's and Children's Hospital
  Adelaide, Australia Recruiting
• Austin Health - Repatriation Hospital
  Heidelberg West, Australia Recruiting

+80 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes

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• Oral insulin vs. subcutaneous insulin in adults with type 1 diabetes

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• Genetic risk score and progression to insulin in type 1 diabetes

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  Recruiting Second Xiangya Hospital of Central South University · Changsha, Hunan · NCT07621445

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.