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RecruitingPhase 3

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Eli Lilly and Company · NCT07223593

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1205
US sites recruiting
28
Study start
October 31, 2025
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Orforglipron; Placebo

Conditions: Peripheral Arterial Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • St. Vincent's Birmingham Hospital

    Birmingham, AL 35205

    Site contact: Christopher DeGroat

  • Mercy Gilbert Medical Center

    Gilbert, AZ 85297

    Site contact: 602-214-0886

  • Del Sol Research Management, LLC

    Tucson, AZ 85715

    Site contact: 520-257-3881

  • Valley Clinical Trials, LLC dba Flourish Research

    Northridge, CA 91325

    Site contact: 818-280-4220

  • The Cardiovascular Center

    Redding, CA 96001

    Site contact: 281-944-3610

  • InvivoCure

    Van Nuys, CA 91405

    Site contact: 859-509-0084

  • Interventional Cardiology Medical Group

    West Hills, CA 91307

    Site contact: 818-702-8800

  • Lakeview Institute of Clinical Research

    Leesburg, FL 34748

    Site contact: 352-782-0606

  • Inpatient Research Clinic

    Miami Lakes, FL 33014

    Site contact: 786-502-4303

  • Floridian Clinical Research, LLC

    Miami Lakes, FL 33016-1518

    Site contact: 305-330-9977

  • St Johns Center for Clinical Research

    Saint Augustine, FL 32086

    Site contact: 904-209-0043

  • ASHA Clinical Research - Munster, LLC

    Hammond, IN 46324

    Site contact: 219-803-6649

  • Indiana University Health Methodist Hospital

    Indianapolis, IN 46202

    Site contact: Rolf Kreutz

  • Deaconess Clinic- Gateway

    Newburgh, IN 47630

    Site contact: 812-490-4505

  • Flourish Research - Bowie

    Bowie, MD 20715

    Site contact: 410-824-1341

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, MI 48098

    Site contact: 248-312-0025

  • Capital Area Research, LLC

    Camp Hill, PA 17011

    Site contact: 717-441-1725

  • The Jackson Clinic

    Jackson, TN 38305

    Site contact: 731-660-8396

  • East Coast Institute for Research - Jefferson City

    Jefferson City, TN 37760

    Site contact: Pragnesh Patel

  • Biopharma Informatic, LLC

    Houston, TX 77084

    Site contact: 281-944-3610

  • Research Physicians Network, LLC

    Houston, TX 77089

    Site contact: 832-847-1724

  • Sherman Clinical Research

    Sherman, TX 75090

    Site contact: 903-771-4093

  • NextStage Clinical Research - Waco

    Waco, TX 76712

    Site contact: Donald Cross

  • Alpine Research Organization

    Clinton, UT 84015

    Site contact: 801-791-2206

  • Stroobants Cardiovascular Center

    Lynchburg, VA 24501

    Site contact: Supawat Ratanapo

  • Clinical Research Partners, LLC

    Richmond, VA 23226

    Site contact: 804-477-3045

  • Gershon Pain Specialists

    Virginia Beach, VA 23454

    Site contact: 757-496-2050

  • Eastside Research Associates

    Redmond, WA 98052

    Site contact: 425-869-6828

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
Efficacy and Safety of Orforglipron in Participants With… (NCT07223593) | Bored Studies