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

NCT07222137 · tracked via the Priya Life Science Japan tracker

Sponsor

Eli Lilly and Company

Phase

Phase 3

Started

2026-01-12

Last updated

2026-09-22

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Baricitinib →Placebo

Baricitinib: Administered orally

Placebo: Administered orally

Study summary

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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

35 Years

Healthy volunteers

Inclusion Criteria: * Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening * Have Stage 1b or Stage 2 type 1 diabetes * Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening Exclusion Criteria: * Have any other type of diabetes * 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 infection

Primary outcome measure(s)

Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes — Baseline up to approximately 5 years

Trial sites (113)

Facility	City	Region	Status
Sansum Diabetes Research Institute	Santa Barbara	California	Not Yet Recruiting
Tallahassee Memorial HealthCare	Tallahassee	Florida	Recruiting
University of South Florida	Tampa	Florida	Suspended
University of Iowa	Iowa City	Iowa	Recruiting
Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa	Recruiting
Novak Center for Children's Health	Louisville	Kentucky	Not Yet Recruiting
Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania	Not Yet Recruiting
University of Virginia	Charlottesville	Virginia	Recruiting
Women's and Children's Hospital	Adelaide	Australia	Recruiting
Box Hill Hospital	Box Hill	Australia	Recruiting
Royal Brisbane and Women's Hospital	Brisbane	Australia	Recruiting
Centre for Children's Health Research	Brisbane	Australia	Recruiting
Royal Children's Hospital	Melbourne	Australia	Not Yet Recruiting
The Royal Melbourne Hospital	Parkville	Australia	Recruiting
Perth Children's Hospital	Perth	Australia	Recruiting
Sydney Children's Hospital	Randwick	Australia	Recruiting
The Children's Hospital at Westmead	Westmead	Australia	Recruiting
UZ Brussel	Brussels	Belgium	Recruiting
Cliniques universitaires Saint-Luc	Brussels	Belgium	Not Yet Recruiting
Antwerp University Hospital	Edegem	Belgium	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
CHU UCL Namur/Site Sainte Elisabeth	Namur	Belgium	Recruiting
Freire Pesquisa Clínica	Belo Horizonte	Brazil	Recruiting
Centro de Diabetes Curitiba	Curitiba	Brazil	Recruiting
Hospital Universitario Walter Cantidio	Fortaleza	Brazil	Recruiting
Cendi - Endocrinologia e Diabetes	Goiânia	Brazil	Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM	Marília	Brazil	Recruiting
Universidade Federal do Rio de Janeiro	Rio de Janeiro	Brazil	Recruiting
Instituto de Pesquisa Clinica	São Paulo	Brazil	Recruiting
CPCLIN	São Paulo	Brazil	Recruiting
IBTED - Tecnologia e Educação em Diabetes	São Paulo	Brazil	Recruiting
Hospital das Clinicas FMUSP	São Paulo	Brazil	Recruiting
Alberta Children's Hospital	Calgary	Canada	Not Yet Recruiting
Alberta Diabetes Institute	Edmonton	Canada	Not Yet Recruiting
BC Diabetes Office	Vancouver	Canada	Recruiting
Oulun yliopistollinen sairaala	Oulu	Finland	Recruiting
Tampereen yliopistollinen sairaala	Tampere	Finland	Recruiting
Turku University Hospital	Turku	Finland	Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel	Bron	France	Not Yet Recruiting
Centre Hospitalier Sud Francilien	Corbeil-Essonnes	France	Not Yet Recruiting

+ 73 more sites — see the full list on the official registry below.

On this site

📄 Olumiant (baricitinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07222137 on ClinicalTrials.gov ↗ ← All trials in Japan