Recruiting
Phase 3

Orforglipron

Sponsor:

Eli Lilly and Company

Code:

NCT07223593

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Placebo

Study Details

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 58 weeks.

Conditions

Peripheral Arterial Disease

Study ID

NCT07223593

Start date

Oct 31, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

1205 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orforglipron

Participants will receive orforglipron orally

placebo comparator: Placebo

Participants will receive placebo orally

Interventions

Orforglipron

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Percent Change from Baseline in Maximum Walking Distance [ Time Frame: Baseline, Week 52 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

St. Vincent's Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35205

Principal Investigator:

Christopher DeGroat

Mercy Gilbert Medical Center

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

602-214-0886

Principal Investigator:

Nabil Dib, MD, Msc,

Del Sol Research Management, LLC

Recruiting

Tucson, Arizona, United States, 85715

Contacts

520-257-3881

Principal Investigator:

Carl Diener

Valley Clinical Trials, LLC dba Flourish Research

Recruiting

Northridge, California, United States, 91325

Contacts

818-280-4220

Principal Investigator:

Christopher Chow

The Cardiovascular Center

Recruiting

Redding, California, United States, 96001

Contacts

281-944-3610

Principal Investigator:

Mohamed Hussein Khan, MD

InvivoCure

Recruiting

Van Nuys, California, United States, 91405

Contacts

859-509-0084

Principal Investigator:

Rodney Samaan

Interventional Cardiology Medical Group

Recruiting

West Hills, California, United States, 91307

Contacts

818-702-8800

Principal Investigator:

Farhad Rafii

Lakeview Institute of Clinical Research

Recruiting

Leesburg, Florida, United States, 34748

Contacts

352-782-0606

Principal Investigator:

Khai Chang

Inpatient Research Clinic

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

786-502-4303

Principal Investigator:

Alexis Gutierrez

Floridian Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33016-1518

Contacts

305-330-9977

Principal Investigator:

Gilberto Concepcion

St Johns Center for Clinical Research

Recruiting

Saint Augustine, Florida, United States, 32086

Contacts

904-209-0043

Principal Investigator:

Ameeth Vedre

ASHA Clinical Research - Munster, LLC

Recruiting

Hammond, Indiana, United States, 46324

Contacts

219-803-6649

Principal Investigator:

Mohan Kesani

Indiana University Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Rolf Kreutz

Deaconess Clinic- Gateway

Recruiting

Newburgh, Indiana, United States, 47630

Contacts

812-490-4505

Principal Investigator:

Sridhar Banuru

Flourish Research - Bowie

Recruiting

Bowie, Maryland, United States, 20715

Contacts

410-824-1341

Principal Investigator:

Sara Collins

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Recruiting

Troy, Michigan, United States, 48098

Contacts

248-312-0025

Principal Investigator:

Neil Fraser

Capital Area Research, LLC

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Contacts

717-441-1725

Principal Investigator:

Venkatesh Nadar

The Jackson Clinic

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

731-660-8396

Principal Investigator:

Antwan Robinson

East Coast Institute for Research - Jefferson City

Recruiting

Jefferson City, Tennessee, United States, 37760

Principal Investigator:

Pragnesh Patel

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77084

Contacts

281-944-3610

Principal Investigator:

Imran Ahmed Dar, MD

Research Physicians Network, LLC

Recruiting

Houston, Texas, United States, 77089

Contacts

832-847-1724

Principal Investigator:

Nadish Garg, MD

Sherman Clinical Research

Recruiting

Sherman, Texas, United States, 75090

Contacts

903-771-4093

Principal Investigator:

Tariq Yousuf

NextStage Clinical Research - Waco

Recruiting

Waco, Texas, United States, 76712

Principal Investigator:

Donald Cross

Alpine Research Organization

Recruiting

Clinton, Utah, United States, 84015

Contacts

801-791-2206

Principal Investigator:

Justin Mansfield

Stroobants Cardiovascular Center

Recruiting

Lynchburg, Virginia, United States, 24501

Principal Investigator:

Supawat Ratanapo

Clinical Research Partners, LLC

Recruiting

Richmond, Virginia, United States, 23226

Contacts

804-477-3045

Principal Investigator:

Robert Call

Gershon Pain Specialists

Recruiting

Virginia Beach, Virginia, United States, 23454

Contacts

757-496-2050

Principal Investigator:

Steven Gershon

ERA Health Research - CardioNow - Lynnwood

Recruiting

Lynnwood, Washington, United States, 98036

Contacts

425-869-6828

Principal Investigator:

Mahesh Mulumudi

Eastside Research Associates

Recruiting

Redmond, Washington, United States, 98052

Contacts

425-869-6828

Principal Investigator:

Christopher Price

THEO Medical Concorde

Recruiting

Laval, Canada, H7G 2E6

Contacts

438-320-7171

Principal Investigator:

Mohamed Medhi Khider

Alpha Recherche Clinique - Lévis

Recruiting

Lévis, Canada, G6V 0C9

Contacts

418-380-1112

Principal Investigator:

Steeve Kwan Tat

KMH Cardiology Centres - Stoney Creek

Recruiting

Stoney Creek, Canada, L8J 3W2

Contacts

905 855 1860

Principal Investigator:

Fatima Merali

Corcare

Recruiting

Toronto, Canada, M1B 5N1

Contacts

416-284-4744

Principal Investigator:

Paul Galiwango

Cardio 1 Medical Clinic

Recruiting

Winnipeg, Canada, R3L 1Z5

Contacts

204-287-5222 ext 104

Principal Investigator:

Peiman Malek Marzban

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.