臨床研究等提出・公開システム

Date of registration	Aug. 20, 2026
Last modified on	Aug. 20, 2026
Trial ID	jRCT2031260413

Scientific Title	A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (J2S-MC-GZMV)
Public Title	A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (J2S-MC-GZMV)

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		Aug. 17, 2026
Target sample size		606
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 physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria: * Current or former smokers with a smoking history of greater than or equal to (>=) 10 pack-years * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)/forced vital capacity (FVC) less than (<) 70 percent (%) * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade >=2 * Exacerbation history of >=2 moderate or >=1 severe exacerbations within the year prior to inclusion. * Background double therapy [long-acting B2-agonists (LABA) + long-acting muscarinic antagonists (LAMA)] or triple therapy [inhaled corticosteroids (ICS) + LABA + LAMA)] for 3 months prior to randomization with a stable dose of medication for >=1 month prior to screening.
	Exclusion Criteria	- Have a known pre-existing, clinically important lung condition other than COPD. - Have a current or recent acute, active infection before screening and up to randomization.
	Age Minimum	40age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pulmonary Disease, Chronic Obstructive
Intervention(s)		DRUG: Brenipatide(Other Name: LY3537031) Brenipatide administered SC DRUG: Placebo Placebo administered SC DRUG: Standard of Care SOC (Study Arms) Experimental: Brenipatide Dose 1 Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC). Interventions: Drug: Brenipatide Drug: Standard of Care Experimental: Brenipatide Dose 2 Brenipatide high dose administered SC in combination with SOC. Interventions: Drug: Brenipatide Drug: Standard of Care Placebo Comparator: Placebo Placebo administered SC in combination with SOC. Interventions: Drug: Placebo Drug: Standard of Care
Primary Outcome(s)		Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) [Time Frame: Baseline through Week 36]

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Sugiura Clinic Instractional Review Board
Address	301,4-4-16 Honmachi, Kawaguchi-city, Saitama, Saitama
Telephone	+81-42-648-5551
E-Mail	sugiura-irb@eps.co.jp
Approval Status	Approval
Date of approval	May. 22, 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)	NCT07759245
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States/Argentina/Austria/Canada/China/Czechia/Denmark/France/Germany/Hungary/India/Mexico/Poland/Puerto Rico/Romania/South Korea/United Kingdom