jRCT2031250570
Not yet recruiting
Not Applicable
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 (J2A-MC-GZPR)
Not provided0 sites1,205 target enrollmentStarted: TBD
ConditionsPeripheral Arterial Disease
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,205
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
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
Investigators
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