Diabetes Mellitus, Type 1Phase 3NCT07222332
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
A Phase 3 study testing Baricitinib in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 131 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 35 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 131 sitesin 20 countries
- Study dates
- 5 Feb 2026to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
131 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
131 sites in 20 countries
Brazil15 sites, 15 recruiting
- Recruiting
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, 79080-190
Delcio da Silva Junior
- Recruiting
Quanta Diagnóstico e Terapia
Curitiba, 80045170
5541999736442
Rosangela Rea
- Recruiting
Centro de Diabetes Curitiba
Curitiba, 80810-040
554130231252
André Vianna
- Recruiting
Centro De Diabetes Metabolismo E Endocrinologia
Fortaleza, 60175-047
5585996190895
ADRIANA FORTI
- Recruiting
Cendi - Endocrinologia e Diabetes
Goiânia, 74230-035
5562992240229
Nelson Rassi
- Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
55 14 21051477
José Sgarbi
- Recruiting
Instituto da Crianca com Diabetes
Porto Alegre, 91350-250
55133372215
Balduino Tschiedel
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T
Ribeirão Preto, 14051-140
Raphael Liberatore
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro, 21941-590
Melanie Rodacki
- Recruiting
Instituto de Pesquisa Clinica
São Paulo, 01223-001
551127370277
Joao Salles
- Recruiting
CPCLIN
São Paulo, 01228-200
551126303777
Denise Franco
- Recruiting
IBTED - Tecnologia e Educação em Diabetes
São Paulo, 04038-032
551197116-9844
Monica Gabbay
- Recruiting
Clínica Hepatogastro JK
São Paulo, 04077-020
5511963934548
DEBORA NAZATO
- Recruiting
Hospital das Clinicas FMUSP
São Paulo, 05403-000
Maria Elizabeth Rossi da Silva
- Recruiting
CEDOES
Vitória, 29055450
55 27 99933-3330
Queulla Santos
Israel11 sites, 11 recruiting
- Recruiting
Yitzhak Shamir Medical Center
Beer Yaacov, 70300
97289542166
Marianna Rachmiel
- Recruiting
Soroka Medical Center
Beersheba, 8410101
97286244150
Alon Haim
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
97247774411
Ram Weiss
- Recruiting
Linn Medical Center
Haifa, 3515209
97248568685
Baruch Itzhak
- Recruiting
Institute of Diabetes, Technology and Research - Clalit Health
Herzliya, 4600201
972-9-9613210
Eytan Roitman
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
+972-507874590
Gil Leibowitz
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
972-97472559
Victor Vishlitzky
- Recruiting
Schneider Children's Medical Center
Petah Tikva, 4920235
97239253282
Moshe Phillip
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
+97239377183
Idit Dotan
- Recruiting
Sheba Medical Center
Ramat Gan, 5262100
+972035302021
Amir Tirosh
- Recruiting
Sourasky Medical Center
Tel Aviv, 6423906
97236974863
Yael Lebenthal
Australia10 sites, 10 recruiting
- Recruiting
Women's and Children's Hospital
Adelaide, 5006
Jennifer Couper
- Not yet recruiting
Centre for Children's Health Research
Brisbane, 4101
Tony Huynh
- Recruiting
Austin Health - Repatriation Hospital
Heidelberg West, 3081
0394962160
Elif Ekinci
- Recruiting
Ipswich Hospital
Ipswich, 4305
0402112100
Thomas Dover
- Not yet recruiting
Royal Children's Hospital
Melbourne, 3052
Fergus Cameron
- Recruiting
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, 5046
Natalie Giles
- Recruiting
The Royal Melbourne Hospital
Parkville, 3050
John Wentworth
- Recruiting
Perth Children's Hospital
Perth, 6009
Elizabeth Davis
- Recruiting
Sydney Children's Hospital
Randwick, 2031
Kristen Neville
- Recruiting
The Children's Hospital at Westmead
Westmead, 2145
02 9845 3171
Ann Maguire
Belgium9 sites, 9 recruiting
- Not yet recruiting
Université Libre de Bruxelles - Hôpital Erasme
Brussels, 1070
3225556305
Miriam Cnop
- Recruiting
UZ Brussel
Brussels, 1090
0475956681
Willem Staels
- Not yet recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
3227647052
Philippe Lysy
- Recruiting
Antwerp University Hospital
Edegem, 2650
0032 8214364
Christophe De Block
- Recruiting
UZ Gent
Ghent, 9000
Imke Matthys
- Recruiting
UZ Leuven
Leuven, 3000
+3216346994
Chantal Mathieu
- Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
00 32 4 323 34 13
jean-christophe philips
- Recruiting
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000
+32-81-720505
Dominique Beckers
- Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, 5530
+32-81-720505
Dominique Beckers
Spain9 sites, 9 recruiting
- Recruiting
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, 48903
946006000
NANCY PORTILLO NAJERA
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
+34932279846
Antonio-Jesus Blanco-Carrasco
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
34 935565661
Lilian Mendoza
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
Roque Cardona-Hernandez
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
+34621360800
Lía Nattero Chávez
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
34639659866
Luis Vazquez Salvi
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
955012000
Virginia Bellido
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
+34 955013767
Ana Gómez Gila
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
696685777
María Francisca Moreno Macián
Germany8 sites, 8 recruiting
- Not yet recruiting
Hannoversche Kinderheilanstalt
Hanover, 30173
+4951181153331
Mareike Niemeyer
- Recruiting
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
Hof, 95030
0049928114037037
Mesut Durmaz
- Not yet recruiting
Klinikum Karlsburg
Karlsburg, 17495
004938355701397
Petra Augstein
- Recruiting
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
Ludwigshafen am Rhein, 67059
0049621 62900552
Hans-Peter Kempe
- Recruiting
TUM Klinikum
München, 80939
0049 89 3187 2896
Anette Ziegler
- Recruiting
RED-Institut GmbH
Oldenburg, 23758
0049436150630128
Thomas Schaum
- Recruiting
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757
00492241249201
Gerd Horneff
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89075
004973150057401
Christian Denzer
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ilaria Dicembrini
- Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139
barbara piccini
- Recruiting
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, 98125
+390902213023
Fortunato Lombardo
- Recruiting
University of Naples Federico II
Naples, 80131
Enza Mozzillo
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
3903213733350
Ivana Rabbone
- Recruiting
Azienda Ospedale - Università Padova
Padova, 35128
+390498212180
Federico Boscari
- Recruiting
Azienda Ospedale - Università Padova
Padova, 35128
3357940960
Carlo Moretti
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
0458127662
Claudio Maffeis
United Kingdom8 sites, 8 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Sam Philip
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
parth narendran
- Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
Renuka Dias
- Recruiting
Southmead Hospital
Bristol, BS10 5NB
0117 4148125
Georgina Russell
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 2QQ
Loredana Marcovecchio
- Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
Maitrayee Choudhury
- Recruiting
Churchill Hospital
Oxford, OX3 7LE
01865857226
Katharine Owen
- Recruiting
Southampton General Hospital
Southampton, SO16 6YD
02381208518
Nicola Trevelyan
Canada7 sites, 7 recruiting
- Not yet recruiting
Alberta Children's Hospital
Calgary, T3B 6A8
Carol Huang
- Recruiting
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, G7H 5H6
Raphaëlle Chrétien
- Not yet recruiting
Alberta Diabetes Institute
Edmonton, T6G 2E1
Peter Senior
- Recruiting
St. Joseph's Health Care
London, N6A 4V2
519-646-6370
Tamara Spaic
- Recruiting
Centricity Research Ottawa LMC Endocrinology
Ottawa, K2J 0V2
613-505-9704
Nadia Malakieh
- Recruiting
CHUL et Centre mère-enfant Soleil
Québec, G1V 4G2
Martin D'Amours
- Recruiting
BC Diabetes Office
Vancouver, V5Y 3W2
604-683-3734 x 1001
Thomas Elliott
Japan6 sites, 6 recruiting
- Not yet recruiting
Iuhw Ichikawa General Hospital
Ichikawa, 272-0824
81120023812
Daisuke Chujo
- Not yet recruiting
Saitama Medical University Hospital
Iruma, 350-0495
81120023812
Yoichi Oikawa
- Not yet recruiting
Shiga General Hospital
Moriyama, 524-8524
81120023812
Katsuyuki Matsui
- Not yet recruiting
Abeno Medical Clinic
Osaka, 545-0052
81120023812
Tomoyuki Kawamura
- Not yet recruiting
Sendai City Hospital - Asutonagamachi
Sendai, 982-8502
81120023812
Ikuma Fujiwara
- Not yet recruiting
Shizuoka Children's Hospital
Shizuoka, 420-8660
81120023812
Shinichiro Sano
Norway6 sites, 6 recruiting
- Recruiting
Helse Fonna - Haugesund Sjukehus
Haugesund, 5528
+47-92051592
Heiko Bratke
- Recruiting
Akershus Universitetssykehus
Lørenskog, 1478
Christopher Inchley
- Recruiting
Oslo Universitetssykehus Aker
Oslo, 0316
Kari Anne Sveen
- Recruiting
Oslo Universitetssykehus Ullevål
Oslo, 0450
+4797522277
Lars Krogvold
- Recruiting
Stavanger Universitetssykehus
Stavanger, 4011
Sondre Meling
- Recruiting
St. Olavs Hospital
Trondheim, 7030
Torstein Rø
United States5 sites, 5 recruiting
- Recruiting
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
303-724-3861
Andrea Steck
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
434-422-2653
Christine Burt Solorzano
- Recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
361-739-7250
Ana Paez
- Not yet recruiting
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
267-426-7037
Steven Willi
- Recruiting
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308
850-431-5404
Larry Deeb
France5 sites, 5 recruiting
- Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677
33472129525
Marc Nicolino
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
33161693086
Alfred Penfornis
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385
33 491388384
Rachel Reynaud
- Recruiting
Pitie Salpetriere University Hospital
Paris, 75013
Chloé AMOUYAL
- Recruiting
CHU Rangueil
Toulouse, 31059
33 5 61 32 30 18
Pierre Gourdy
Sweden5 sites, 5 recruiting
- Recruiting
ProbarE i Lund AB
Lund, 222 22
46732300450
Anders Luts
- Recruiting
Universitetssjukhuset Örebro
Örebro, 701 85
Frida Sundberg
- Not yet recruiting
Östersunds Sjukhus
Östersund, 831 31
David Nöjdh
- Recruiting
ProbarE i Stockholm AB
Stockholm, 11437
0732300450
Peter Bosson
- Recruiting
Uddevalla Sjukhus
Uddevalla, 451 53
Marcus Lind
Poland4 sites, 4 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Anna Woloszyn-Durkiewicz
- Recruiting
UMED Clinical Trials
Lodz, 92-213
48 607145644
Agnieszka Szadkowska
- Recruiting
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
Agnieszka Szypowska
- Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, 50-368
Agnieszka Zubkiewicz-Kucharska
Portugal4 sites, 4 recruiting
- Recruiting
2Ca Braga
Braga, 4710-243
Ana Sofia Martins
- Recruiting
Centro Materno Infantil do Norte
Porto, 4050
+351914125573
Teresa Maria da Silva Borges Ferreira
- Recruiting
ULSAM - Hospital de Santa Luzia
Viana do Castelo, 4900-858
961790293
Maria Cristina Roque
- Not yet recruiting
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, 4434-502
Marta Ferreira
Ukraine4 sites, 4 recruiting
- Recruiting
Institute of Endocrinology and Metabolism named after Komissarenko
Kiev, 04114
+380976444044
Olesia Zinych
- Recruiting
Kyiv City Endocrinological Center
Kyiv, 01024
Yuliia Komisarenko
- Recruiting
Zakarpattia Endoclinic
Uzhhorod, 88000
+38 050 5958603
Oksana Khyzhnyak
- Recruiting
Vinnytsia Regional Clinical Endocrinology Dispensary
Vinnytsia, 21010
+380432531735
Maryna Vlasenko
Czechia3 sites
- Active, not recruiting
Nemocnice Jihlava
Jihlava, 58633
- Active, not recruiting
Fakultni nemocnice Ostrava
Ostrava, 70852
- Active, not recruiting
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, 14900
Finland3 sites, 3 recruiting
- Recruiting
Oulun yliopistollinen sairaala
Oulu, 90220
Riitta Veijola
- Recruiting
Tampereen yliopistollinen sairaala
Tampere, 33520
358503539956
Sauli Palmu
- Recruiting
Turku University Hospital
Turku, 20520
Jorma Toppari
Netherlands1 site, 1 recruiting
- Recruiting
Diabeter - Rotterdam
Rotterdam, 3011 TA
+31-88-280-7277
Hendrik Aanstoot
About this study
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Baricitinib, Placebo
- Keywords
- T1DM, Children, New-onset, Beta-cell Function
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Participants will receive baricitinib orally Receives: Drug: Baricitinib |
| Placebo | Placebo comparator | Participants will receive placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in C-peptide Area Under the Curve (AUC)
Measured: Baseline, Week 52
Secondary outcomes (9)
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 52
Change from Baseline in Number of Manual Insulin Boluses
Measured: Baseline, Week 52
Rate of Clinically Significant Hypoglycemic Events
Measured: Baseline through Week 52
Change from Baseline in Fasting C-Peptide
Measured: Baseline, Week 52
Change from Baseline in Height
Measured: Baseline, Week 52
Change from Baseline in Mean Total Daily Insulin Dose
Measured during the two weeks prior to the assessment
Measured: Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)
Measured: Baseline, Week 52
Change from Baseline in Matsuda Index
Measured: Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Measured: Predose through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start5 Feb 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222332
- Sponsor's protocol ID
- 27405
- Other IDs
- 2025-522170-36-00, I4V-MC-JAJK, 2025
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
- ClinicalTrials.gov ID
- NCT07222332
- Acronym / sponsor ID
- 27405
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- T1DM, Children, New-onset, Beta-cell Function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: BaricitinibParticipants will receive baricitinib orally |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally |
Who may qualify
- Ages
- 1 year to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- Weigh at least 8 kilograms (kg) (18 pounds) at screening
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: LY3009104Administered orally | Drug | Baricitinib |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Change from Baseline in C-peptide Area Under the Curve (AUC)
Time frame: Baseline, Week 52
9 secondary outcomes
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 52
Change from Baseline in Number of Manual Insulin Boluses
Time frame: Baseline, Week 52
Rate of Clinically Significant Hypoglycemic Events
Time frame: Baseline through Week 52
Change from Baseline in Fasting C-Peptide
Time frame: Baseline, Week 52
Change from Baseline in Height
Time frame: Baseline, Week 52
Change from Baseline in Mean Total Daily Insulin Dose
Time frame: Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)
Time frame: Baseline, Week 52
Change from Baseline in Matsuda Index
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Time frame: Predose through Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
131 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baricitinib in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 131 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 131 sites in Brazil, Israel, Australia, Belgium, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in C-peptide Area Under the Curve (AUC) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.