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

NCT07222332 · tracked via the Priya Life Science UK tracker

Sponsor

Eli Lilly and Company

Phase

Phase 3

Started

2026-02-05

Last updated

2026-09-04

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

BaricitinibPlacebo

Baricitinib: Administered orally

Placebo: Administered orally

Study 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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

35 Years

Healthy volunteers

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

Primary outcome measure(s)

Change from Baseline in C-peptide Area Under the Curve (AUC) — Baseline, Week 52

Trial sites (137)

Facility	City	Region	Status
Barbara Davis Center for Childhood Diabetes	Aurora	Colorado	Recruiting
Tallahassee Memorial HealthCare	Tallahassee	Florida	Recruiting
Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania	Not Yet Recruiting
Driscoll Children's Hospital	Corpus Christi	Texas	Recruiting
University of Virginia	Charlottesville	Virginia	Recruiting
Women's and Children's Hospital	Adelaide	Australia	Recruiting
Centre for Children's Health Research	Brisbane	Australia	Not Yet Recruiting
Austin Health - Repatriation Hospital	Heidelberg West	Australia	Recruiting
Ipswich Hospital	Ipswich	Australia	Recruiting
Royal Children's Hospital	Melbourne	Australia	Not Yet Recruiting
Southern Adelaide Diabetes & Endocrine Services	Oaklands Park	Australia	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
Université Libre de Bruxelles - Hôpital Erasme	Brussels	Belgium	Not Yet Recruiting
UZ Brussel	Brussels	Belgium	Recruiting
Cliniques universitaires Saint-Luc	Brussels	Belgium	Not Yet Recruiting
Antwerp University Hospital	Edegem	Belgium	Not Yet Recruiting
UZ Gent	Ghent	Belgium	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman	Liège	Belgium	Recruiting
CHU UCL Namur/Site Sainte Elisabeth	Namur	Belgium	Not Yet Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne	Yvoir	Belgium	Not Yet Recruiting
Hospital Universitário Maria Aparecida Pedrossian	Campo Grande	Brazil	Recruiting
Quanta Diagnóstico e Terapia	Curitiba	Brazil	Recruiting
Centro de Diabetes Curitiba	Curitiba	Brazil	Recruiting
Centro De Diabetes Metabolismo E Endocrinologia	Fortaleza	Brazil	Recruiting
Cendi - Endocrinologia e Diabetes	Goiânia	Brazil	Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM	Marília	Brazil	Recruiting
Instituto da Crianca com Diabetes	Porto Alegre	Brazil	Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T	Ribeirão Preto	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
Clínica Hepatogastro JK	São Paulo	Brazil	Recruiting
Hospital das Clinicas FMUSP	São Paulo	Brazil	Recruiting
CEDOES	Vitória	Brazil	Recruiting
Alberta Children's Hospital	Calgary	Canada	Not Yet Recruiting

+ 97 more sites — see the full list on the official registry below.

On this site

📄 Olumiant (baricitinib) drug profile →

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Other trials for the same condition

A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting

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

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) Active, not recruiting

Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity Active, not recruiting

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 NCT07222332 on ClinicalTrials.gov ↗ ← All trials in the UK