RECRUITINGPhase 3INTERVENTIONAL
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
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
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Have symptomatic PAD with intermittent claudication of Fontaine Stage II
- Have an Ankle Brachial Index (ABI) of 0.9 or less
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Orforglipron
Administered orally
DRUG
Placebo
Administered orally
Locations (20)
St. Vincent's Birmingham Hospital
Birmingham, Alabama, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Axsendo Clinical Research - Peak Heart & Vascular - Surprise
Surprise, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
The Cardiovascular Center
Redding, California, United States
InvivoCure
Van Nuys, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
Lakeview Institute of Clinical Research
Leesburg, Florida, United States
Inpatient Research Clinic
Miami Lakes, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
St Johns Center for Clinical Research
Saint Augustine, Florida, United States
ASHA Clinical Research - Munster, LLC
Hammond, Indiana, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Deaconess Clinic- Gateway
Newburgh, Indiana, United States
Flourish Research - Bowie
Bowie, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
The Jackson Clinic
Jackson, Tennessee, United States
East Coast Institute for Research - Jefferson City
Jefferson City, Tennessee, United States