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Clinical Trials in the UK / NCT07223593
Recruiting Phase 3

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

NCT07223593 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-10-31
Last updated
2026-09-08

Condition(s) studied

Peripheral Arterial Disease

Investigational drug(s) / intervention(s)

OrforglipronPlacebo

Orforglipron: Administered orally

Placebo: Administered orally

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (161)

FacilityCityRegionStatus
St. Vincent's Birmingham Hospital Birmingham Alabama Recruiting
Mercy Gilbert Medical Center Gilbert Arizona Recruiting
Emvera Health at Peak Heart & Vascular Surprise Surprise Arizona Not Yet Recruiting
Del Sol Research Management, LLC Tucson Arizona Recruiting
Angel City Research Inc. Los Angeles California Not Yet Recruiting
Valley Clinical Trials, LLC dba Flourish Research Northridge California Recruiting
The Cardiovascular Center Redding California Recruiting
InvivoCure Van Nuys California Recruiting
Interventional Cardiology Medical Group West Hills California Recruiting
Rocky Mountain Regional VA Medical Center Aurora Colorado Not Yet Recruiting
Lakeview Institute of Clinical Research Leesburg Florida Recruiting
Inpatient Research Clinic Miami Lakes Florida Recruiting
Floridian Clinical Research, LLC Miami Lakes Florida Recruiting
St Johns Center for Clinical Research Saint Augustine Florida Recruiting
Guardian Research Organization, LLC Winter Park Florida Not Yet Recruiting
ASHA Clinical Research - Munster, LLC Hammond Indiana Recruiting
Indiana University Health Methodist Hospital Indianapolis Indiana Recruiting
Cardiovascular Research of Northwest Indiana Munster Indiana Not Yet Recruiting
Deaconess Clinic- Gateway Newburgh Indiana Recruiting
Flourish Research - Bowie Bowie Maryland Recruiting
Capitol Cardiology Associates - Lanham Office Lanham Maryland Not Yet Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan Recruiting
Capital Area Research, LLC Camp Hill Pennsylvania Recruiting
The Jackson Clinic Jackson Tennessee Recruiting
East Coast Institute for Research - Jefferson City Jefferson City Tennessee Recruiting
Biopharma Informatic, LLC Houston Texas Recruiting
Research Physicians Network, LLC Houston Texas Recruiting
Sherman Clinical Research Sherman Texas Recruiting
NextStage Clinical Research - Waco Waco Texas Recruiting
Alpine Research Organization Clinton Utah Recruiting
Stroobants Cardiovascular Center Lynchburg Virginia Recruiting
Carient Heart & Vascular - Manassas Manassas Virginia Not Yet Recruiting
Clinical Research Partners, LLC Richmond Virginia Recruiting
Gershon Pain Specialists Virginia Beach Virginia Recruiting
ERA Health Research - CardioNow - Lynnwood Lynnwood Washington Recruiting
Eastside Research Associates Redmond Washington Recruiting
CIPREC Buenos Aires Argentina Not Yet Recruiting
CIPREC Buenos Aires Argentina Recruiting
Sanatorio Finochietto Buenos Aires Argentina Recruiting
CEMEDIC Buenos Aires Argentina Recruiting

+ 121 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07223593 on ClinicalTrials.gov ↗ ← All trials in the UK