Orforglipron for peripheral artery disease with intermittent claudication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, double-blind, placebo-controlled study compares once-daily orforglipron to placebo over about 58 weeks in adults with Fontaine Stage II PAD and an ankle-brachial index ≤0.9. Participants are randomized to receive orforglipron or matching placebo and will attend regular clinic visits for safety monitoring and functional walking assessments. Key exclusion criteria include BMI <23 kg/m2, HbA1c >10%, recent peripheral revascularization or major cardiovascular events, and other non-PAD causes limiting walking. The trial is sponsored by Eli Lilly and conducted at several U.S. clinical sites.

Why it matters

Who can join: the full rules

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

Where it's running

• St. Vincent's Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• Mercy Gilbert Medical Center
  Gilbert, Arizona, United States Recruiting
• Del Sol Research Management, LLC
  Tucson, Arizona, United States Recruiting
• Valley Clinical Trials, LLC dba Flourish Research
  Northridge, California, United States Recruiting
• The Cardiovascular Center
  Redding, California, United States Recruiting
• InvivoCure
  Van Nuys, California, United States Recruiting

+119 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.