ATTAIN-PAD

RecruitingPhase 3

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

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

138

Recruiting sites

101

Enrollment

1,205

estimated

Study population

Cardiovascular disease

Key I/E criterion

—

Primary endpoint

•Maximum Walking Distance

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07223593

Org study ID27632

Secondary ID2025-523283-21-00

Secondary IDJ2A-MC-GZPREli Lilly and Company

Timeline

Milestones

Study start2025-10-31actual

Study first posted2025-11-03actual

Last update posted2026-05-22actual

Primary completion2028-06estimated (month precision)

Study completion2028-06estimated (month precision)

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Cardiovascular disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Other clinical outcomes

Heart failure

Patient-reported / QoL

Heart failure

1 endpoint

Secondary/protocol endpoint

Change from Baseline in 6 Minute Walk Test Distance (meters)

Time frame:Baseline, Week 52

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline, Week 52

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (mmHg)

Time frame:Baseline, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score

Time frame:Baseline, Week 52

change from baseline, improvement

Other clinical outcomes

2 endpoints

Primary/protocol endpoint/low confidence

Percent Change from Baseline in Maximum Walking Distance

Time frame:Baseline, Week 52

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percent Change from Baseline in Pain Free Walking Distance

Time frame:Baseline, Week 52

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.