Orforglipron for Peripheral Artery Disease

This study is looking at a medication called orforglipron to see if it's safe and effective for people with Peripheral Artery Disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs, often causing leg pain when walking (intermittent claudication). You might be able to join if you have symptomatic PAD at Fontaine Stage II and an Ankle Brachial Index (ABI) of 0.9 or less. However, you cannot join if your body mass index (BMI) is too low, your Hemoglobin A1c (HbA1c) is too high, or if other conditions limit your walking. The main goal is to see how much your walking distance improves after 52 weeks. The current status of this study is unclear, and it plans to enroll about 1205 participants.

Study design
This study is interventional, meaning participants will receive either orforglipron or a placebo (an inactive substance). It plans to include about 1205 participants.
What's involved
Participation in this study will last about 58 weeks. The primary measurement of walking distance will be taken at the beginning and at Week 52.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 52, and the study lasts about 58 weeks, suggesting follow-up for at least 58 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223593

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Recruiting
PHASE3Ages 18+InterventionalTreatment
Eli Lilly and Company
~1,205 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:OrforglipronPlacebo

At a glance

Recruiting sites
130 of 159 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from Baseline in Maximum Walking Distance
Measured over Baseline, Week 52
Peripheral Arterial Disease
159 sites across 29 states
Japan25
China18
Argentina13
India11
Australia9
Brazil8
Poland8
Canada7
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Percent Change from Baseline in Maximum Walking DistanceBaseline, Week 52

    On a constant load treadmill test