NCT07223593 · Eli Lilly and Company
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
(ATTAIN-PAD)
What this study is about
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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Gilbert, Arizona
- Surprise, Arizona
- Tucson, Arizona
- Northridge, California
- Redding, California
- Van Nuys, California
- West Hills, California
- Leesburg, Florida
- Miami Lakes, Florida
- Saint Augustine, Florida
- Hammond, Indiana
And 16 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations