Status:
RECRUITING
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Have symptomatic PAD with intermittent claudication of Fontaine Stage II
- Have an Ankle Brachial Index (ABI) of 0.9 or less
Exclusion
- 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
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
1205 Patients enrolled
Trial Details
Trial ID
NCT07223593
Start Date
October 31 2025
End Date
June 1 2028
Last Update
December 24 2025
Active Locations (132)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Vincent's Birmingham Hospital
Birmingham, Alabama, United States, 35205
2
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
3
Axsendo Clinical Research - Peak Heart & Vascular - Surprise
Surprise, Arizona, United States, 85378
4
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715