A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT07222137
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 delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.

Key Dates

Start date
Jan 12, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
150 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

Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes [ Time Frame: Baseline up to approximately 5 years ]

Central Contacts

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

Locations (7)

FacilityCityStateZIPSite coordinators
Tallahassee Memorial HealthCareTallahasseeFlorida32308
850-431-5404
Larry Deeb (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33612-
University of IowaIowa CityIowa52242
319-356-4511
Michael Tansey (PRINCIPAL_INVESTIGATOR)
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50266
515-329-6800
Anuj Bhargava (PRINCIPAL_INVESTIGATOR)
Novak Center for Children's HealthLouisvilleKentucky40202
502-629-5820
Kupper Wintergerst (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104
267-426-7037
Steven Willi (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Aaron Misakian (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tallahassee, FL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Tallahassee Memorial HealthCare· Tallahassee, FLUniversity of South Florida· Tampa, FLUniversity of Iowa· Iowa City, IAIowa Diabetes and Endocrinology Research Center· West Des Moines, IANovak Center for Children's Health· Louisville, KYChildren's Hospital of Philadelphia (CHOP)· Philadelphia, PA

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