A Phase 3 interventional study of Baricitinib and Placebo in Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Recruiting at 112 sites in 19 countries. Open to participants aged 1 Year to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive baricitinib orally
Drug: Baricitinib
Participants will receive placebo orally
Drug: Placebo
Administered orally
Also known as: LY3009104
Administered orally
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Time frame: Baseline up to approximately 5 years
Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)
Time frame: Baseline, Week 52
Change from Baseline in Glucose AUC
Time frame: Baseline, Week 52
Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)
Time frame: Baseline, Week 52
Change from Baseline in Height
Time frame: Baseline, Week 52
Change from Baseline in Body Mass Index (BMI) Percentile
Time frame: Baseline, Week 52
Change in Glucose Time in Range Between 70 and 180 mg/dL (inclusive)
Time frame: Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Time frame: Predose through Week 24
PK: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
Time frame: Predose through Week 24
Change from Baseline in Matsuda Index
Time frame: Baseline, Week 52
Showing the first 100 of 112 sites across 19 countries. Choose a country and city above to see the rest.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Jan 2026 (actual). Primary completion is estimated for Jul 2031, 66 months after the start.
Of 78 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's planned 66 months is above that.
Counting every sponsor, half of 106 studies reached it within 18 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Baricitinib