NCT07223593RecruitingPhase 3
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
Eli Lilly and Company170 sites in 7 countries1,205 target enrollmentStarted: October 31, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,205
- Locations
- 170
- Primary Endpoint
- Percent Change from Baseline in Maximum Walking Distance
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Orforglipron
Experimental
Participants will receive orforglipron orally
Intervention: Orforglipron (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent Change from Baseline in Maximum Walking Distance
Time Frame: Baseline, Week 52
On a constant load treadmill test
Secondary Outcomes
- Percent Change from Baseline in Pain Free Walking Distance(Baseline, Week 52)
- Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score(Baseline, Week 52)
- Change from Baseline in 6 Minute Walk Test Distance (meters)(Baseline, Week 52)
- Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)(Baseline, Week 52)
- Change from Baseline in Systolic Blood Pressure (mmHg)(Baseline, Week 52)
Investigators
Study Sites (170)
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