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Taking people in United StatesPhase 3

Orforglipron for people with peripheral artery disease

Tests daily orforglipron in adults with peripheral artery disease.

Key facts

Who runs it
Eli Lilly and Company
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 sitesAlso in 17 other countries, 130 sites
Registry title
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Status
Recruiting
Phase
Phase 3
People taking part
1,205 people, planned
Started
31 Oct 2025
Expected to end
Jun 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Orforglipron
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease (narrowed leg arteries) that causes leg pain when walking. It tests orforglipron, taken by mouth once daily, against a placebo (dummy pill).

Age
18 Years and older
Sex
All
Disease stage
Symptomatic peripheral artery disease with leg pain when walking (intermittent claudication), Fontaine Stage II.
Earlier treatment
No procedure to reopen leg arteries (peripheral revascularization) within 90 days before screening, and none planned during the trial.
Biomarker or test result
Ankle Brachial Index (ABI) of 0.9 or less. This test compares blood pressure at the ankle and the arm.

Main reasons for not taking part

  • Body mass index (BMI) less than 23 kg/m2
  • HbA1c greater than 10% (86 mmol/mol)
  • Walking limited by conditions other than PAD, or planned leg surgery or other surgery affecting walking
  • Stroke, mini-stroke, heart attack, heart or neck artery procedure, or hospital stay for unstable angina within 60 days before screening
  • Heart failure, New York Heart Association class III - IV

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

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

Who cannot take part

  • 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)

Where in United States

Also in 17 other countries, 130 sites

  • 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

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • OrforglipronTreatment being tested

    Participants will receive orforglipron orally

  • PlaceboPlacebo, for comparison

    Participants will receive placebo orally

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Orforglipron for people with peripheral artery diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
4 November 2026