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Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Orforglipron (drug), Placebo (drug)
How long the study runs: Study runs about 32 months (dates as stated)
About the drug or intervention: Orforglipron — drug: Administered orally · Placebo — drug: Administered orally
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 1,205
Started: 2025-10-31
Last checked: 2026-10

Plain English Summary

What is this study?

• Testing a new treatment for peripheral arterial disease
• Phase3 - 1,205 participants
• 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)

Who can take part?

• Ages 18 Years and over
• Diagnosed with peripheral arterial disease

Where?

• London - Imperial College Healthcare NHS Trust, Charing Cross Hospital
• Plymouth - Derriford Hospital
• Stoke-on-Trent - Royal Stoke University Hospital
• Swansea - Swansea University
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Peripheral Arterial Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

What the study is looking for

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

Who cannot take part

✗Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)
✗Have red blood cell level 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...

See the 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

Where Is This Study? (5 UK sites)

Imperial College Healthcare NHS Trust, Charing Cross Hospital

London W6 8RF, United Kingdom

Recruiting

Site contact (verified)

Alun DaviesPrincipal Investigator

Derriford Hospital

Plymouth Pl6 8DH, United Kingdom

Recruiting

Site contact (verified)

Devender MittapalliPrincipal Investigator

01752431822

Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting

Site contact (verified)

Arun PherwaniPrincipal Investigator

Swansea University

Swansea SA2 8PP, United Kingdom

Recruiting

Site contact (verified)

Stephen BainPrincipal Investigator

07710641345

Moorgreen Hospital

West End SO30 3JB, United Kingdom

Recruiting

Site contact (verified)

Sarah BrewsterPrincipal Investigator

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-10