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Orforglipron for peripheral artery disease with intermittent claudication

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

Phase 3 Interventional Eli Lilly and Company · NCT07223593

This trial will test whether taking orforglipron once daily helps people with Fontaine II peripheral artery disease (intermittent claudication) and is safe.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1205 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations138 sites (Birmingham, Alabama and 137 other locations)
Trial IDNCT07223593 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with symptomatic Fontaine Stage II PAD and an ankle-brachial index of 0.9 or less who meet BMI and glycemic criteria and have no recent revascularization or major cardiovascular events are ideal candidates.

Not a fit: People with BMI under 23 kg/m2, very high HbA1c (>10%), walking limitations from non-PAD causes, recent peripheral revascularization or recent major cardiovascular events, or advanced heart failure are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, orforglipron could reduce claudication symptoms and improve walking distance and daily function while demonstrating an acceptable safety profile.

How similar studies have performed: Orforglipron is a relatively new oral GLP-1 receptor modulator with prior trials focused on metabolic outcomes, and using it specifically to improve PAD symptoms is a novel approach with limited direct evidence to date.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 137 other locations

+88 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peripheral Arterial Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.