Recruiting
Phase 3

Baricitinib

Sponsor:

Eli Lilly and Company

Code:

NCT07222332

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 1 - 35

Healthy Volunteers: Not accepted

Interventions

Baricitinib

Placebo

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT07222332

Start date

Feb 5, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 35

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Baricitinib

Participants will receive baricitinib orally

placebo comparator: Placebo

Participants will receive placebo orally

Interventions

Baricitinib

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Change from Baseline in C-peptide Area Under the Curve (AUC) [ Time Frame: Baseline, Week 52 ]

Central Contacts and Locations

Central contacts

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

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Barbara Davis Center for Childhood Diabetes

Recruiting

Aurora, Colorado, United States, 80045

Contacts

303-724-3861

Principal Investigator:

Andrea Steck

Tallahassee Memorial HealthCare

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

850-431-5404

Principal Investigator:

Larry Deeb

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

361-739-7250

Principal Investigator:

Ana Paez

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

434-422-2653

Principal Investigator:

Christine Burt Solorzano

CIUSSS- saguenay-Lac-Saint-Jean

Recruiting

Chicoutimi, Canada, G7H 5H6

Principal Investigator:

Raphaëlle Chrétien

Centricity Research Ottawa LMC Endocrinology

Recruiting

Ottawa, Canada, K2J 0V2

Contacts

613-505-9704

Principal Investigator:

Nadia Malakieh

BC Diabetes Office

Recruiting

Vancouver, Canada, V5Y 3W2

Contacts

604-683-3734 x 1001

Principal Investigator:

Thomas Elliott

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • T1DM
  • Children
  • New-onset
  • Beta-cell Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.