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HomeTrials › NCT07223593

Other · Phase 3 · Recruiting now

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

NCT07223593 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is recruiting now at 30 US sites. It's studying Orforglipron, Placebo for peripheral arterial disease.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeOrforglipron, Placebo
Study length~2.6 years overall
Planned participants1,205
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

Alabama

  • St. Vincent's Birmingham Hospital — Birmingham · Opening soon

Arizona

  • Mercy Gilbert Medical Center — Gilbert · Recruiting now
  • Emvera Health at Peak Heart & Vascular Surprise — Surprise · Recruiting now
  • Del Sol Research Management, LLC — Tucson · Recruiting now

California

  • Valley Clinical Trials, Inc. — Northridge · Recruiting now
  • The Cardiovascular Center — Redding · Recruiting now
  • InvivoCure — Van Nuys · Recruiting now
  • Interventional Cardiology Medical Group — West Hills · Recruiting now

Florida

  • Lakeview Institute of Clinical Research — Leesburg · Recruiting now
  • Inpatient Research Clinic — Miami Lakes · Recruiting now
  • Floridian Clinical Research, LLC — Miami Lakes · Recruiting now
  • St Johns Center for Clinical Research — Saint Augustine · Recruiting now

Indiana

  • ASHA Clinical Research - Munster, LLC — Hammond · Recruiting now
  • Indiana University Health Methodist Hospital — Indianapolis · Recruiting now
  • Deaconess Clinic- Gateway — Newburgh · Recruiting now

Maryland

  • Flourish Research - Bowie — Bowie · Recruiting now

Michigan

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy · Recruiting now

Pennsylvania

  • Capital Area Research, LLC — Camp Hill · Recruiting now

Tennessee

  • The Jackson Clinic — Jackson · Recruiting now
  • East Coast Institute for Research - Jefferson City — Jefferson City · Recruiting now

Texas

  • Biopharma Informatic, LLC — Houston · Recruiting now
  • Research Physicians Network, LLC — Houston · Recruiting now
  • Sherman Clinical Research — Sherman · Recruiting now
  • NextStage Clinical Research - Waco — Waco · Recruiting now

Utah

  • Alpine Research Organization — Clinton · Recruiting now

Virginia

  • Stroobants Cardiovascular Center — Lynchburg · Recruiting now
  • Clinical Research Partners, LLC — Richmond · Recruiting now
  • Gershon Pain Specialists — Virginia Beach · Recruiting now

Washington

  • ERA Health Research - CardioNow - Lynnwood — Lynnwood · Recruiting now
  • Eastside Research Associates — Redmond · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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