臨床研究等提出・公開システム

Date of registration	Jan. 07, 2026
Last modified on	Aug. 04, 2026
Trial ID	jRCT2021250041

Scientific Title	A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged >=1 to <36 Years (I4V-MC-JAJJ)
Public Title	A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults (I4V-MC-JAJJ)

Contact for Scientific Queries	Name	Masaki Takeshi
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com
Contact for Public Queries	Name	Trial Guide Call Center
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 07, 2026
Actual date of first enrollment		June. 15, 2026
Target sample size		150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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
	Age Minimum	1age old over
	Age Maximum	35age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Diabetes Mellitus, Type 1
Intervention(s)		DRUG: Baricitinib(Other Name: LY3009104) Administered orally DRUG: Placebo Administered orally (Study Arms) Experimental: Baricitinib Participants will receive baricitinib orally Interventions: Drug: Baricitinib Placebo Comparator: Placebo Participants will receive placebo orally Interventions: Drug: Placebo
Primary Outcome(s)		Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes [ Time Frame: Baseline up to approximately 5 years

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Seino Internal Medicine Clinic Institutional Review Board
Address	192-2 Kaisei 6-chome, Koriyama-shi, Fukushima, Japan, Fukushima
Telephone	+81-24-983-1024
E-Mail	hs1024@seino-chinc.jp
Approval Status	Approval

Plan to share IPD	Yes
Plan description	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.

Secondary ID(s)	NCT07222137
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States/Australia/Belgium/Brazil/Canada/Finland/France/Germany/Israel/Italy/Netherlands/Norway/Poland/Portugal/Spain/Sweden/United Kingdom

History of Changes

No	Publication date
3	Aug. 04, 2026	(this page)	Changes
2	July. 28, 2026	Detail	Changes
1	Jan. 07, 2026	Detail

List of change history