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Recruiting Phase 3 NCT07222332

NCT07222332 A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

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Clinical Trial Summary
NCT ID NCT07222332
Status Recruiting
Phase Phase 3
Sponsor Eli Lilly and Company
Condition Diabetes Mellitus, Type 1
Study Type INTERVENTIONAL
Enrollment 300 participants
Start Date 2026-02-05
Primary Completion 2028-07

Eligibility & Interventions

Sex All sexes
Min Age 1 Year
Max Age 35 Years
Study Type INTERVENTIONAL
Interventions
BaricitinibPlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 300 participants in total. It began in 2026-02-05 with a primary completion date of 2028-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility 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

Contact & Investigator

Central Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

✉ LillyTrials@Lilly.com

📞 317-615-4559

Principal Investigator

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

Frequently Asked Questions

Who can join the NCT07222332 clinical trial?

This trial is open to participants of all sexes, aged 1 Year or older, up to 35 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07222332 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.

Is NCT07222332 currently recruiting?

Yes, NCT07222332 is actively recruiting participants. Contact the research team at LillyTrials@Lilly.com for enrollment information.

Where is the NCT07222332 trial being conducted?

This trial is being conducted at Aurora, United States, Tallahassee, United States, Philadelphia, United States, Corpus Christi, United States and 11 additional locations.

Who is sponsoring the NCT07222332 clinical trial?

NCT07222332 is sponsored by Eli Lilly and Company. The principal investigator is 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) at Eli Lilly and Company. The trial plans to enroll 300 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology