臨床研究等提出・公開システム

Date of registration	Dec. 16, 2025
Last modified on	Dec. 16, 2025
Trial ID	jRCT2031250570

Scientific Title	A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial (J2A-MC-GZPR)
Public Title	Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (J2A-MC-GZPR)

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		Dec. 16, 2025
Target sample size		1205
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 symptomatic PAD with intermittent claudication of Fontaine Stage II - Have an Ankle Brachial Index (ABI) of 0.9 or less
	Exclusion Criteria	- Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2) - Have Hemoglobin A1c (HbA1c) greater than 10% - Have walking ability limited by conditions other than PAD - Have a planned lower limb surgery or any other surgery affecting walking ability - Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial - Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening - Have heart failure presently classified as being in New York Heart Association class III - IV
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Peripheral Arterial Disease
Intervention(s)		DRUG: Orforglipron(Other Name: LY3502970) Administered orally DRUG: Placebo Administered orally (Study Arms) Experimental: Orforglipron Participants will receive orforglipron orally Interventions: Drug: Orforglipron Placebo Comparator: Placebo Participants will receive placebo orally Interventions: Drug: Placebo
Primary Outcome(s)		Percent Change from Baseline in Maximum Walking Distance On a constant load treadmill test [ Time Frame: Baseline, Week 52 ]

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Institutional Review Board of Nakakinen clinic
Address	745-5 Nakadai, Naka-shi, Ibaraki, Ibaraki
Telephone	+81-29-353-2800
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)	NCT07223593
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States/Argentina/Australia/Brazil/Canada/China/France/India/Netherlands/Poland/Puerto Rico/Slovakia/South Korea/Taiwan/United Kingdom