Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT07223593
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-10-30
• Study First Submitted QC: 2025-10-30
• Status Verified: 2025-11
• Study First Posted: 2025-11-03
• Last Update Submitted: 2025-11-03
• Last Update Posted: 2025-11-04
• Study Start: 2025-12-01
• Primary Completion: 2028-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron	Orforglipron	Participants will receive orforglipron orally
Placebo	Placebo	Participants will receive placebo orally

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Maximum Walking Distance	Baseline, Week 52	On a constant load treadmill test

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Pain Free Walking Distance	Baseline, Week 52	On a constant load treadmill test
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

Trial Locations

Locations (106)

Floridian Clinical Research, LLC; 🇺🇸 Miami Lakes, Florida, United States

Deaconess Clinic- Gateway; 🇺🇸 Newburgh, Indiana, United States

Flourish Research - Bowie; 🇺🇸 Bowie, Maryland, United States

Eastside Research Associates; 🇺🇸 Redmond, Washington, United States

Unity Health Toronto, St. Michael's Hospital; 🇨🇦 Toronto, Canada

Heilongjiang Provincial Hospital; 🇨🇳 Harbin, China

Vijan Hospital & Research Centre; 🇮🇳 Nashik, India

Sir Ganga Ram Hospital; 🇮🇳 New Delhi, India

National Hospital Organization Kanazawa Medical Center; 🇯🇵 Kanazawa, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Japan

Scroll for more (96 remaining)