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Recruiting Phase 3 NCT07222137

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

Phase 3 – large-scale trial before approval
Conditions: Diabetes Mellitus, Type 1

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 17
Australia (1)
Women's and Children's Hospital
Adelaide
Belgium (1)
UZ Brussel
Brussels
NOT_YET_RECRUITING
Brazil (1)
Freire Pesquisa Clínica
Belo Horizonte
Canada (1)
Alberta Diabetes Institute
Edmonton
NOT_YET_RECRUITING
Finland (1)
Oulun yliopistollinen sairaala
Oulu
NOT_YET_RECRUITING
France (1)
Hospices Civils de Lyon - Hopital Louis Pradel
Bron
NOT_YET_RECRUITING
Germany (1)
Universitaetsklinikum Augsburg
Augsburg
NOT_YET_RECRUITING
Israel (1)
Yitzhak Shamir Medical Center
Beer Yaacov
Italy (1)
Ospedale Pediatrico Salesi
Ancona
Japan (1)
Abeno Medical Clinic
Abeno
Netherlands (1)
Diabeter - Rotterdam
Rotterdam
NOT_YET_RECRUITING
Norway (1)
Haukeland Universitetssjukehus
Bergen
Poland (1)
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw
Spain (1)
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo
Sweden (1)
Skånes Universitetssjukhus Malmö
Malmo
United Kingdom (1)
Queen Elizabeth Hospital Birmingham
Birmingham
NOT_YET_RECRUITING
United States (1)
Tallahassee Memorial HealthCare
Tallahassee , Florida
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
35 Years
Healthy volunteers
No
Start date
12.01.2026
Completion date
01.07.2031
Registry ID
NCT07222137
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.