臨床研究等提出・公開システム

Date of registration	May. 20, 2026
Last modified on	May. 20, 2026
Trial ID	jRCT2031260143

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-C (J2S-MC-GZMT)
Public Title	A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C) (J2S-MC-GZMT)

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	Pending

Anticipated date of first enrollment		June. 15, 2026
Target sample size		342
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	- Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7 - 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
	Exclusion Criteria	- Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, 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 Constipation
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 with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks [Time Frame: Week 9 to 16]

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Yamauchi Clinic Institutional Review Board
Address	1-15-19 Jiyugaoka, Meguro-ku, Tokyo, Japan, 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)	NCT07545772
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States