Under construction – not a live service
Sign in
Taking people in United KingdomPhase 3

Orforglipron for people with peripheral artery disease

Tests daily orforglipron in adults with peripheral artery disease.

Key facts

Who runs it
Eli Lilly and Company
Where
London, Plymouth, Stoke-on-Trent, Swansea, and West End, United KingdomSee the 5 sitesAlso in 17 other countries, 160 sites
Registry title
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Status
Recruiting
Phase
Phase 3
People taking part
1,205 people, planned
Started
31 Oct 2025
Expected to end
Jun 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Orforglipron
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease (narrowed leg arteries) that causes leg pain when walking. It tests orforglipron, taken by mouth once daily, against a placebo (dummy pill).

Age
18 Years and older
Sex
All
Disease stage
Symptomatic peripheral artery disease with leg pain when walking (intermittent claudication), Fontaine Stage II.
Earlier treatment
No procedure to reopen leg arteries (peripheral revascularization) within 90 days before screening, and none planned during the trial.
Biomarker or test result
Ankle Brachial Index (ABI) of 0.9 or less. This test compares blood pressure at the ankle and the arm.

Main reasons for not taking part

  • Body mass index (BMI) less than 23 kg/m2
  • HbA1c greater than 10% (86 mmol/mol)
  • Walking limited by conditions other than PAD, or planned leg surgery or other surgery affecting walking
  • Stroke, mini-stroke, heart attack, heart or neck artery procedure, or hospital stay for unstable angina within 60 days before screening
  • Heart failure, New York Heart Association class III - IV

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Have symptomatic 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 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 walking ability limited by conditions other than PAD
  • Have heart failure presently classified as being in New York Heart Association class III - IV
  • Have Hemoglobin A1c (HbA1c) greater than 10%
  • Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)

Where in United Kingdom

Also in 17 other countries, 160 sites

  • Imperial College Healthcare NHS Trust, Charing Cross HospitalLondon, United KingdomContact: Alun Davies (principal investigator)Taking people
  • Derriford HospitalPlymouth, United KingdomContact: Devender Mittapalli (principal investigator)Taking people
  • Royal Stoke University HospitalStoke-on-Trent, United KingdomContact: Arun Pherwani (principal investigator)Taking people
  • Swansea UniversitySwansea, United KingdomContact: Stephen Bain (principal investigator)Taking people
  • Moorgreen HospitalWest End, United KingdomContact: Sarah Brewster (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • OrforglipronTreatment being tested

    Participants will receive orforglipron orally

  • PlaceboPlacebo, for comparison

    Participants will receive placebo orally

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Orforglipron for people with peripheral artery diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
4 November 2026