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 Company
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugOrforglipron
Administered orally
- DrugPlacebo
Administered orally
Locations (138)
- St. Vincent's Birmingham HospitalBirmingham, Alabama
- Mercy Gilbert Medical CenterGilbert, Arizona
- Axsendo Clinical Research - Peak Heart & Vascular - SurpriseSurprise, Arizona
- Del Sol Research Management, LLCTucson, Arizona
- Valley Clinical Trials, Inc.Northridge, California
- The Cardiovascular CenterRedding, California