Peripheral Arterial Disease
Conditions
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.
Interventions
DRUGOrforglipron
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Maximum Walking Distance | Baseline, Week 52 | On a constant load treadmill test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Argentina, Australia, Brazil, Canada, China, France, India, Israel, Japan, Netherlands, Poland, Puerto Rico, Slovakia, South Korea, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed