RecruitingPhase 3NCT07223593
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
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
Sponsor
Eli Lilly and Company
Enrollment
1,205 participants
Start Date
Oct 31, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- Have symptomatic PAD with intermittent claudication of Fontaine Stage II
- Have an Ankle Brachial Index (ABI) of 0.9 or less
Exclusion Criteria7
- 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
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Interventions
DRUGOrforglipron
Administered orally
DRUGPlacebo
Administered orally
Locations(139)
View Full Details on ClinicalTrials.gov
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NCT07223593
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