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Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Peripheral Arterial Disease

Interventions: Orforglipron, Placebo

Countries: United States, Argentina, Australia, Brazil, Canada, China, France, India

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (159)

Birmingham, Alabama, United States
Gilbert, Arizona, United States
Surprise, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Northridge, California, United States
Redding, California, United States
Van Nuys, California, United States
West Hills, California, United States
Aurora, Colorado, United States
Leesburg, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Saint Augustine, Florida, United States
Hammond, Indiana, United States
Indianapolis, Indiana, United States
Munster, Indiana, United States
Newburgh, Indiana, United States
Bowie, Maryland, United States
Lanham, Maryland, United States
Troy, Michigan, United States
Camp Hill, Pennsylvania, United States
Jackson, Tennessee, United States
Jefferson City, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Sherman, Texas, United States
Waco, Texas, United States
Clinton, Utah, United States
Lynchburg, Virginia, United States
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