臨床研究等提出・公開システム

Date of registration	May. 22, 2026
Last modified on	July. 22, 2026
Trial ID	jRCT2031260148

Scientific Title	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D (J2S-MC-GZMS)
Public Title	A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D) (J2S-MC-GZMS)

Contact for Scientific Queries	Name	Takeshi Masaki
	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		April. 16, 2026
Target sample size		531
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	- Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and <25% of bowel movements with BSFS Types 1 or 2 - Based on the daily eDiary collection during the screening period: * Have average of worst abdominal pain score of >=3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization * Have at least 4 days per week with a maximum BSFS >=5 AND with at least 2 days of the 4 days per week with a maximum BSFS >=6 during the 14 consecutive days prior to randomization - Have had no major changes in diet in the 4 weeks prior to screening
	Exclusion Criteria	- Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria - Have a history of inflammatory or immune-mediated gastrointestinal disorders - Have a known clinically significant gastric emptying abnormality
	Age Minimum	18age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Irritable Bowel Syndrome Diarrhea
Intervention(s)		DRUG: LY3537031(Other Name: Brenipatide) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: LY3537031 LY3537031 administered subcutaneously (SC) Interventions: Drug: LY3537031 Placebo Comparator: Placebo Placebo administered SC Interventions: Drug: Placebo
Primary Outcome(s)		Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days [Time Frame: Week 9 to Week 16]

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Yamauchi Clinic Research Ethics Committee
Address	3-4-7 Toranomon Minato-ku, Tokyo, Tokyo
Telephone	+81-3-6777-1490
E-Mail	c-irb_ug@neues.co.jp
Approval Status	Approval
Date of approval	Mar. 23, 2026

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)	NCT07545759
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States/Belgium/Canada/China/Germany/Mexico/Poland/Spain/United Kingdom

History of Changes

No	Publication date
2	July. 22, 2026	(this page)	Changes
1	May. 22, 2026	Detail

List of change history