Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
ConditionPeripheral Arterial Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Have symptomatic PAD with intermittent claudication of Fontaine Stage II
Have an Ankle Brachial Index (ABI) of 0.9 or less
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Orforglipron
DrugAdministered orally
Placebo
DrugAdministered orally
Treatment groups
1,205 Participants
are divided into 2 treatment groupsGroup A: OrforglipronExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change from Baseline in Maximum Walking Distance
On a constant load treadmill test
Time frame
Baseline, Week 52Secondary outcomes
1
Percent Change from Baseline in Pain Free Walking Distance
On a constant load treadmill test
Time frame
Baseline, Week 522
Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score
Time frame
Baseline, Week 523
Change from Baseline in 6 Minute Walk Test Distance (meters)
Time frame
Baseline, Week 524
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame
Baseline, Week 52Sponsors and contacts
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Source ClinicalTrials.gov