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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Eli Lilly and Company
Study ID
NCT07222332
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Feb 5, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Participants will receive baricitinib orally
  • Placebo Comparator: Placebo
    Participants will receive placebo orally

Primary Outcome Measure

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

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Barbara Davis Center for Childhood DiabetesAuroraColorado80045
303-724-3861
Andrea Steck (PRINCIPAL_INVESTIGATOR)
Tallahassee Memorial HealthCareTallahasseeFlorida32308
850-431-5404
Larry Deeb (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104
267-426-7037
Steven Willi (PRINCIPAL_INVESTIGATOR)
Driscoll Children's HospitalCorpus ChristiTexas78411
361-739-7250
Ana Paez (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
434-924-5956
Christine Burt Solorzano (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Barbara Davis Center for Childhood Diabetes· Aurora, COTallahassee Memorial HealthCare· Tallahassee, FLChildren's Hospital of Philadelphia (CHOP)· Philadelphia, PADriscoll Children's Hospital· Corpus Christi, TXUniversity of Virginia· Charlottesville, VA

Related Studies