Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT07223593

Run by

Eli Lilly and Company

People needed

1205

Starts

2025-10-31

Expected to finish

2028-06-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have symptomatic PAD with intermittent claudication of Fontaine Stage II
• Have an Ankle Brachial Index (ABI) of 0.9 or less

You may not qualify if…

• 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

Where it is running

• Alpine Research Organization — Clinton, Utah, United States (enrolling)
• St. Vincent's Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
• Sherman Clinical Research — Sherman, Texas, United States (enrolling)
• NextStage Clinical Research - Waco — Waco, Texas, United States (enrolling)
• Valley Clinical Trials, LLC dba Flourish Research — Northridge, California, United States (enrolling)
• The Cardiovascular Center — Redding, California, United States (enrolling)
• Del Sol Research Management, LLC — Tucson, Arizona, United States (enrolling)
• Interventional Cardiology Medical Group — West Hills, California, United States (enrolling)
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States (enrolling)
• Lakeview Institute of Clinical Research — Leesburg, Florida, United States (enrolling)
• Inpatient Research Clinic — Miami Lakes, Florida, United States (enrolling)
• Floridian Clinical Research, LLC — Miami Lakes, Florida, United States (enrolling)
• St Johns Center for Clinical Research — Saint Augustine, Florida, United States (enrolling)
• ASHA Clinical Research - Munster, LLC — Hammond, Indiana, United States (enrolling)
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
• InvivoCure — Van Nuys, California, United States (enrolling)
• Deaconess Clinic- Gateway — Newburgh, Indiana, United States (enrolling)
• Flourish Research - Bowie — Bowie, Maryland, United States (enrolling)
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States (enrolling)
• Capital Area Research, LLC — Camp Hill, Pennsylvania, United States (enrolling)
• The Jackson Clinic — Jackson, Tennessee, United States (enrolling)
• East Coast Institute for Research - Jefferson City — Jefferson City, Tennessee, United States (enrolling)
• Biopharma Informatic, LLC — Houston, Texas, United States (enrolling)
• Research Physicians Network, LLC — Houston, Texas, United States (enrolling)
• Stroobants Cardiovascular Center — Lynchburg, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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