Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Key facts
- Where
- Aurora, Birmingham, Bowie, Camp Hill, Clinton, Gilbert, Hammond, Houston, Indianapolis, Jackson, Jefferson City, Lanham, Leesburg, Los Angeles, Lynchburg, Lynnwood, Miami Lakes, Munster, Newburgh, Northridge, Redding, Redmond, Richmond, Saint Augustine, Sherman, Surprise, Troy, Tucson, Van Nuys, Virginia Beach, Waco, West Hills, and Winter Park, United StatesSee the 35 sites
- Phase
- Phase 3
Where in United States
- Rocky Mountain Regional VA Medical CenterAurora, United StatesContact: David Saxon (principal investigator)Not yet recruiting
- St. Vincent's Birmingham HospitalBirmingham, United StatesContact: Christopher DeGroat (principal investigator)Taking people
- Flourish Research - BowieBowie, United StatesContact: Sara Collins (principal investigator)Taking people
- Capital Area Research, LLCCamp Hill, United StatesContact: Venkatesh Nadar (principal investigator)Taking people
- Alpine Research OrganizationClinton, United StatesContact: Justin Mansfield (principal investigator)Taking people
- Mercy Gilbert Medical CenterGilbert, United StatesContact: Georges Nseir (principal investigator)Taking people
- ASHA Clinical Research-Munster, LLCHammond, United StatesContact: Mohan Kesani (principal investigator)Taking people
- Biopharma Informatic, LLCHouston, United StatesContact: Imran Ahmed Dar, MD (principal investigator)Taking people
- Research Physicians Network, LLCHouston, United StatesContact: Nadish Garg, MD (principal investigator)Taking people
- Indiana University Health Methodist HospitalIndianapolis, United StatesContact: Rolf Kreutz (principal investigator)Taking people
- The Jackson ClinicJackson, United StatesContact: Antwan Robinson (principal investigator)Taking people
- East Coast Institute for Research, Jefferson CityJefferson City, United StatesContact: Pragnesh Patel (principal investigator)Taking people
- Capitol Cardiology Associates - Lanham OfficeLanham, United StatesContact: Vineet Venugopal (principal investigator)Not yet recruiting
- Lakeview Institute of Clinical ResearchLeesburg, United StatesContact: Khai Chang (principal investigator)Taking people
- Angel City Research, Inc.Los Angeles, United StatesContact: Parham Parto (principal investigator)Not yet recruiting
- Stroobants Cardiovascular CenterLynchburg, United StatesContact: Supawat Ratanapo (principal investigator)Taking people
- ERA Health Research - CardioNow - LynnwoodLynnwood, United StatesNo longer taking part
- Floridian Clinical Research, LLCMiami Lakes, United StatesContact: Gilberto Concepcion (principal investigator)Taking people
- Inpatient Research ClinicMiami Lakes, United StatesContact: Alexis Gutierrez (principal investigator)Taking people
- Cardiovascular Research of Northwest IndianaMunster, United StatesContact: Wail Asfour (principal investigator)Not yet recruiting
- Deaconess Clinic- GatewayNewburgh, United StatesContact: Sridhar Banuru (principal investigator)Taking people
- Valley Clinical Trials, LLC dba Flourish ResearchNorthridge, United StatesContact: Christopher Chow (principal investigator)Taking people
- The Cardiovascular CenterRedding, United StatesContact: Mohamed Hussein Khan, MD (principal investigator)Taking people
- Eastside Research AssociatesRedmond, United StatesContact: Christopher Price (principal investigator)Taking people
- Clinical Research Partners, LLCRichmond, United StatesTaking people
- St. Johns Center for Clinical ResearchSaint Augustine, United StatesContact: Ameeth Vedre (principal investigator)Taking people
- Sherman Clinical ResearchSherman, United StatesContact: Tariq Yousuf (principal investigator)Taking people
- Emvera Health at Peak Heart & Vascular SurpriseSurprise, United StatesNo longer taking part
- Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesContact: Neil Fraser (principal investigator)Taking people
- Del Sol Research Management, LLCTucson, United StatesContact: Carl Diener (principal investigator)Taking people
- InvivoCureVan Nuys, United StatesContact: Rodney Samaan (principal investigator)Taking people
- Gershon Pain SpecialistsVirginia Beach, United StatesContact: Steven Gershon (principal investigator)Taking people
- NextStage Clinical Research - WacoWaco, United StatesContact: Donald Cross (principal investigator)Taking people
- Interventional Cardiology Medical GroupWest Hills, United StatesContact: Farhad Rafii (principal investigator)Taking people
- Guardian Research Organization LLCWinter Park, United StatesContact: Ashish Gupta (principal investigator)Not yet recruiting
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).