NIPH Clinical Trials Search

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Peripheral Arterial Disease
Date of first enrollment	16/12/2025
Target sample size	1205
Countries of recruitment	United States,Japan,Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,France,Japan,India,Japan,Netherlands,Japan,Poland,Japan,Puerto Rico,Japan,Slovakia,Japan,South Korea,Japan,Taiwan,Japan,United Kingdom,Japan
Study type	Interventional
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

Outcome(s)

Primary Outcome	Percent Change from Baseline in Maximum Walking Distance On a constant load treadmill test [ Time Frame: Baseline, Week 52 ]
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Have symptomatic PAD with intermittent claudication of Fontaine Stage II - Have an Ankle Brachial Index (ABI) of 0.9 or less
Exclude 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