Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Key facts
- Where
- Dordrecht, Eindhoven, and HB Nijmegen, NetherlandsSee the 3 sites
- Phase
- Phase 3
Where in Netherlands
- Albert Schweitzer ZiekenhuisDordrecht, NetherlandsTaking people
- Catharina Ziekenhuis StichtingEindhoven, NetherlandsTaking people
- Radboud UMCHB Nijmegen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07223593EU 2025-523283-21-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
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 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 walking ability limited by conditions other than PAD; Have heart failure presently classified as being in New York Heart Association class III - IV; Have Hemoglobin A1c (HbA1c) greater than 10%; Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2).